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AFDO Journeys Toward the Integrated Food Safety System Vision

As an AFDO industry member, Remco Products Corporation is proud to have participated in the 121st Association of Food and Drug Officials Conference this June. Over 400 members from federal, state, and local agencies, as well as members of industry groups, trade associations, consumer organizations, and academia, made the trip to Houston for the recent conference.

AFDO has, over time, become a recognized voice in promoting uniform, simplified, and efficient laws, regulations and guidelines related to food safety and public health. Their humble beginning predates the existence of the FDA by 10 years when in 1896, two state commissioners from Michigan and Ohio met in Toledo to discuss the difficulties of manufacturing food in one state and shipping it to another, where the same product may not have complied with the local statutory regulations.

The push for states to collaborate and come to a mutually acceptable solution eventually resulted in a streamlined regulatory solution across the states. With time, AFDO became a forerunner in publishing model codes and guidance for various foods, which have been used to formulate aligned state regulations. The defining moment arrived in 1998, when AFDO was the first to offer a vision of a national Integrated Food Safety System (IFSS) that would empower state and local authorities to collaborate effectively with their federal counterparts. The crowning glory came with the passage of FSMA in 2011, which shifted the FDA’s focus from the reactive to the preventive mode of addressing food safety risks, which also mandated the adoption of IFSS across the food supply network.

The 121st AFDO Conference was informative and covered many food safety and regulatory topics. Some of the important presentations delivered were on:

  1. The role of CDC’s National Environmental Reporting System as an assessment tool for investigating foodborne disease outbreaks.
  2. The importance of online tools like FoodSHIELD that promote real-time collaboration between agencies to help respond effectively whenever there is a food safety issue.
  3. E-commerce trends and how it influences pick-and-pack grocery delivery.
  4. The emerging use of social media to track public views and respond to foodborne illness outbreaks.
  5. The culture of clean, and an industry perspective of detergents and sanitizers.
  6. The benefits of third party auditing in driving a food safety culture in an organization.
  7. The importance of maintaining sanitary conditions in a facility to prevent the potential for criminal liability if a firm is linked to an outbreak.
  8. The problems faced by state and local agencies when regulating leased commercial kitchens and viable recommendations to solving the food safety challenges.
  9. Greater focus on continuous training, development, and collaboration between inspectors from various agencies mainly through the activities of Partnership for Food Protection and through the education programs of International Food Protection Training Institute.
  10. The hurdles and opportunities encountered when regulating the cannabis industry.

In its quest towards a true IFSS, AFDO has stood for its values – to connect the public and private sectors, to share scientific knowledge, best practices, and collaborate on mutual goals, to impact the regulatory environment positively by speaking in one unified voice, and to protect public health and the welfare of the community.

Remco Products Corporation, your partners in hygiene, is aware of regulation’s role in shaping the future of our industry, and our team is always working to consistently provide high-quality, color-coded, material handling and hygienically designed tools and implements to our clients in the food and beverage sector.


How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

HARPC covers food safety concerns beyond Critical Control Points and is mandated by the FDA for most facilities, with some exemptions. Instead of only looking at process steps where controls can be applied (as in HACCP plans), HARPC relies on the applicable FDA regulations, standards, and guidance documents to develop a Preventive Controls Plan.

How HACCP Works

HACCP is a globally recognized risk-based preventative approach recommended by the Codex Alimentarius Commission (or the ‘Food Code’) and the National Advisory Committee on Microbiological Criteria for Foods. It commonly focuses on controlling the three main food safety hazards: biological, chemical, and physical. The primary goals (in order of priority) are to prevent occurrences of the hazard, or eliminate, or reduce the food safety hazard to acceptable or safe levels.

 The HACCP plans are developed, implemented, and maintained by a multi-disciplinary team and the entire process is facilitated by a HACCP Coordinator, a person who is sufficiently knowledgeable and skilled in food safety concepts and principles and has undertaken a training program that has preferably been accredited by the International HACCP Alliance. The responsible person must review the HACCP plan at least annually, or whenever there are significant changes in food safety design layout, processes, product composition, or technology.

 The HACCP program is legally mandated for meat and poultry establishments (under USDA jurisdiction) and juice and seafood processing establishments (under FDA’s jurisdiction). Even though the HACCP program for several food establishments may be voluntary (unless specified by regulations, industrial standards, or by customers), it does not absolve a facility from implementing Current Good Manufacturing Practices (as provided in the 21 CFR 110 legal document) and other relevant pre-requisite program requirements necessary to maintain the safety and legality of the food products. In the Food Code, prior to HACCP recommendation, there are General Principles of Food Hygiene (provided in 10 sections) that have to be followed. Auditors, inspectors, customers, and other stakeholders may inspect the HACCP or food safety plan.

12 Steps of HACCP:

  • Assemble the multidisciplinary HACCP team
  • Describe the product
  • Identify its intended use
  • Construct a flow diagram
  • Conduct on-site confirmation of the flow diagram, and draw up the plant schematic
  • List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  • Determine Critical Control Limits (Principle 2)
  • Establish Critical Limits for each CCP (Principle 3)
  • Establish a monitoring system for each CCP (Principle 4)
  • Establish corrective actions (Principle 5)
  • Establish verification procedures (Principle 6)
  • Establish documentation and record-keeping (Principle 7)

How HARPC Works

In brief, this preventive control system mandated by FDA’s FSMA Act is to be implemented by all food establishments unless specifically exempted. Thus, it applies to food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold, or import food, and for those firms exporting foodstuff to the US. The FDA has issued implementation deadlines for each of the different facility types (kindly refer to updated guidelines on the FDA site, Within a HARPC plan, the food safety hazards assessment is broader; generally, the following risks are considered:

  • Biological, physical, chemical, and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposed material, parasites, allergens, and unapproved food and color additives
  • Naturally occurring hazards
  • Unintentionally introduced hazards
  • Intentionally introduced hazards, including acts of terrorism

Preventive controls are science-based and shall be adequate to significantly minimize or prevent identified hazards “known or reasonably foreseeable” for each type of food subject to the relevant FDA regulation. The HARPC plan is developed, implemented, and maintained by a team of “preventive controls qualified individuals” as defined in the FSMA act, who have been trained or are sufficiently conversant with the FDA FSMA Final Rule for Preventive Controls for Human Food, and any other relevant rulemakings, such as the Final Rules on Animal Food, Produce Safety or Foreign Supplier Verification Program etc. (for more information, refer to the FDA site,  The responsible person must review the HARPC plan at least once every 3 years (if no significant changes occur in the plan) or whenever there is a significant change at the facility that might increase a known hazard or introduce a new one.

7 Steps of HARPC

  1. Assess the hazards—This includes the normal product-specific hazards, along with a broad range of other hazards (listed above) and facility-specific concerns such as food defense and emergency management issues.
  2. Institute Preventive Controls—These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification, and more.
  3. Monitor effectiveness of the controls—Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
  4. Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and non-conforming food product.
  5. Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
  6. Follow proper and required recordkeeping—As with any FDA ruling, nothing is properly done until it’s recorded.
  7. Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be reevaluated.

Recap of Some Key Differences:

Hazard Analysis Method

The three conventional types of hazards that are addressed in the HACCP plans—physical, chemical, and biological—are accompanied by many more concerns in HARPC plans.

Radiation, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food or color additives, naturally occurring hazards, and intentionally and unintentionally introduced hazards round out the list of HARPC-related hazards.

Critical Control Points Versus Preventive Controls

Critical Control Points during process steps are central to HACCP. Each control point must include measurable critical limits—the temperature and length of time a sauce must be held at, for example, as a kill step. The objective of each control step is either to prevent, eliminate, or reduce food safety hazards to a safe and acceptable level. Food safety measures that aren’t specific to the process, such as personnel hygiene, are covered under Standard Operating Procedures (SOPs).

HARPC focuses on Preventive Controls that are science- or risk-based, and should be adequate to “significantly minimize or prevent” known or foreseeable hazards for each type of food subject to the federal regulations.


To learn more about HACCP, download our whitepaper, “HACCP Planning for Food Safety,” or contact our knowledgeable customer service representatives at or at 317.876.9856. Contact us today to schedule a complementary on-site consultation regarding HACCP and HARPC plans.

To view more information about this and other sanitation topics, visit



Food and Drug Administration. (2015). FSMA final rule for preventive controls for human food.

Joint FAO/WHO Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, & World Health Organization. (2003). Codex Alimentarius: Food hygiene, basic texts. Food & Agriculture Org.

US Food and Drug Administration. (2011). Food safety modernization act (FSMA). Public Law, 2011, 111-353.



FDA Final Rule on the Sanitary Transportation of Food Compliance Gains Momentum


The FDA’s final rule on the sanitary transportation of food went into effect June 6, 2016. Though larger carriers, shippers, and receivers should have their compliance plans in place, smaller companies (fewer than 500 employees and less than $27.5 million in annual receipts) still have two years from the rule publication date to comply with the requirements.

This final rule—the sixth of seven rulemakings for FSMA—was based on a combination of the Sanitary Transportation of Food Act of 2005 and about 240 submissions from transportation companies, food safety organizations, consumer advocacy groups, and more.

The rulemaking has been proposed to ensure:

  1. Proper refrigeration during transportation of foods that require it;
  2. That vehicles and food storage are adequately cleaned and sanitized; and
  3. That there is adequate protection for food during transport.

Waivers have been proposed to exempt carriers, shippers, and receivers who hold valid permits and are inspected under National Conference on Interstate Milk Shipments (NCIMS) Grade ‘‘A’’ Milk Safety Program only when they’re shipping Grade A milk and milk products. The exemption should also apply to retail and food service operations that hold valid permits only when they are engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.

Foods that are covered under the ruling includes all FDA-regulated human food and animal (including pet) food, with a few exemptions:

  • Compressed food gasses
  • Live animals
  • Transportation performed by a farm
  • Food completely enclosed containers or packaging that doesn’t require Temperature Control for Safety (TCS)

Though the FDA doesn’t have exact numbers or predictions on how this ruling will affect food safety, they have estimated that the total first year cost will be $162.7 million, with the total annual cost estimated at $93.5 million.

Requirements Addressed in the Ruling

Vehicles and Transportation Equipment

All transportation equipment and vehicles used in food transport (not including exemptions) must be adequately cleanable in design and material. Transportation equipment is defined as equipment used in transportation, such as bins, bulk containers, pallets, pumps, loading systems, totes, and more.

Transportation Operations

Responsibility for making sure food is transported in a safe manner (including temperature controls, measures like segregation or product isolation, and basic sanitary measures like hand washing) must be assigned to a supervisor or a management team. There are also additional concerns for shippers, receivers, and carriers:

Shippers: Must specify the conditions necessary to safely transport food in writing (such as cleaning procedures and temperature controls) to the carrier. Shippers are responsible for the visual inspection of the vehicle and the transportation equipment and must declare that they have been properly cleaned and sanitized. The shipper must also check to ensure that any necessary pre-cooling has taken place.

Shippers and Receivers: Must provide convenient handwashing locations for carrier employees to use when the food products aren’t completely enclosed in containers. Shippers and receivers are also responsible for loading and unloading the food products in a safe and sanitary manner.

Carriers: Must provide a sanitary transportation method for food. They should pre-cool refrigerated units as requested by the shipper, and demonstrate that the appropriate temperature is met, if requested by the shipper.

Information Exchange

Procedures must be established for information to be exchanged among shippers, carriers, and receivers. Disclosures about what was previously carried and the cleaning and sanitation measures that were taken are imperative for food safety. For example, information such as possible allergen cross-contact between food the carrier just unloaded and what he or she is about to load is vital to keeping food safe. Sharing such information helps prevent cross-contact and cross-contamination.


The FDA now requires carriers to undergo training if they have an agreement with shippers that they’ll be responsible for the transportation operations. The FDA isn’t prescribing a length to the training, or even specific topics that must be covered. The goal is to raise awareness about food safety procedures; not to train carriers on specific duties.


Shippers and carriers both bear the burden of record-keeping. Shippers must hold specific records that demonstrate they have adequately provided safe transport information to carriers for at least 12 months, though these records may be stored off-site. Carriers must have records for agreements between them and the shippers about the safe transport information for 12 months after the agreements are in effect. They also must have records detailing training for employees involved in food transport, and keep those records for 12 months after the person is no longer performing those duties.

The sanitary transportation of food ruling should affect an estimated 83,609 businesses. The information it contains may not have a predictable outcome on food safety per the FDA, but the administration hopes to improve food safety during transportation by regulating food temperature, cleaning, and sanitation of food transportation equipment and vehicles, and ensuring food is protected during transportation.

FDA Inspection Checklist

Remco Products presents Food Industry Counsel’s FDA Inspection Checklist as a part of our commitment to bringing our audience the best information in the food industry. We don’t endorse any legal services or provide legal advice. For legal services or advice, please consult your attorney.  You can also contact Shawn Stevens, the author of this post, at

What to do Before, During and After Your Next FDA Inspection

Food Industry Counsel, LLC is pleased to provide you with the most comprehensive and useful FDA Inspection Checklist available. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) was given the mission of overhauling the safety of the nation’s food supply. The new FSMA regulations written by FDA are now coming into effect, and the agency is now aggressively enforcing its new rules during routine inspections. Within the coming years, FDA Investigators will conduct an onsite inspection of every food facility in the U.S.

Here are FDA’s new enforcement priorities during routine unannounced inspections:

(1) To carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements;

(2) To conduct extensive Zone 1, Zone 2, Zone 3 and Zone 4 microbiological sampling inside all food facilities to find evidence of pathogenic contamination;

(3) To require recalls if the percentage of FDA samples testing positive for Listeria Monocytogenes, Salmonella or other pathogens exceeds FDA thresholds;

(4) To compare the DNA fingerprints of any pathogens found in the facility against the >1,000,000 human isolates stored in the CDC’s PulseNet database to identify any matches, and then require food product recalls if any matches are found; and

(5) To initiate broader investigations, including criminal investigations, against food companies whose products are found to have caused human illness. Against this backdrop, all companies should begin taking steps to prepare for their next FDA inspection.

Companies can use the following checklists to ensure that they have completed the needed preparations before the FDA Investigators arrive, to help effectively navigate the inspection process once the inspection is underway, and to appropriately respond to any FDA criticisms once the FDA inspection concludes.



Much of the work needed to ensure that the FDA inspection ends successfully should be completed long before the FDA Investigators arrive. All companies should begin work immediately to ensure that they have accomplished the following critical tasks:

□ Identify a Meeting Space: Identify a space within the facility to host the FDA investigators when they arrive. This might be a conference room or a vacant office with sufficient desk space to review large amounts of records. The space selected, however, should be free of any records (in binders, boxes or on computers) which FDA Investigators could access, unsupervised, while they occupy the space.

□ Assign Designated Individuals: Assign a primary and secondary Designated Individual (DI) for each facility to serve as the liaison with the FDA Investigators once they arrive. DIs should coordinate vacation time (and time off) to ensure that one DI will always be available in the event FDA arrives.

□ Complete PCQI Training: Ensure that the primary DI has received FDA’s Preventive Control Qualified Individual (PCQI) Training. Although the training is not required under FDA regulations to become a Qualified Individual, FDA Investigators will typically expect the training to be completed by at least one facility employee.

□ Finalize Written Food Safety Systems: Ensure that the company’s written food safety systems are finalized, and the primary and secondary DIs are familiar with each of the elements of the plans. Depending upon the size of the business and the nature of the products, this could include GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food Defense Plan, and Produce Safety Plan.

□ Ensure Ease of Records Access: Ensure that the supporting records for each of the programs are organized and maintained in such a way that the DI can immediately retrieve the past three months of records for FDA review. Although FDA requires the majority of these records to be maintained for at least two years, the FDA investigators will typically ask only to review records for the preceding three months.

□ Document Corrective Actions Properly: Ensure that, in the event there is a deviation, you are documenting all corrective actions correctly. All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

□ Upgrade Sanitation Flashlights: This may seem obvious, but many facilities are still using flashlights are severely underpowered or outdated. Be sure to equip your sanitation employees with the same high-power flashlights that the FDA Investigators will use so that your employees will be able to see (and then clean) what the FDA would observe with its own flashlights when it arrives.

□ Review Allergen Controls: FDA is requiring companies to recall vast amounts of products if the FDA Investigators find, during their visual inspection, that the companies’ allergen controls are not adequate. Make sure that your ingredient labels are accurate, and that opportunities for cross-contact are being guarded against and avoided.

□ Conduct Environmental Monitoring: If your company processes readyto-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. Ensure that an appropriate program is developed and implemented before FDA arrives.

□ Conduct More Environmental Sampling: Because FDA will collect between 100 and 200 microbiological samples from your facility, it is critical to know exactly what FDA will find before it arrives. Thus, you should “Play FDA for a Day,” and conduct your own FDA-style facility swabbing, to identify and immediately correct any hidden problems. If done correctly, and if your swabbing and testing plan is developed with the assistance of legal counsel, the final testing results can be kept confidential.

□ Develop a Microbiological Sample Retain Policy: If, after reporting your testing results, your lab retains your isolates or testing materials indefinitely, create a policy requiring the lab to discard all testing material within 24 hours after testing. This is appropriate as long as the records of the final results are maintained.

□ Develop a Companion Sample Policy: When FDA collects food product or environmental samples, some companies elect to collect companion samples at the same time. Although we typically counsel against this practice, if you choose to collect companion samples, make sure to have a policy in place governing exactly how those samples will be handled, tested and/or discarded following collection.

□ Develop a “No Photographs” Policy: In many cases, FDA Investigators will insist on taking photographs while inspecting the processing environment. If you have a corporate policy which prevents visitors from taking photographs, you may be able to use the policy to prevent FDA from taking pictures.

□ Develop a “Do Not Sign” Policy: Sometimes, during an FDA inspection, the FDA Investigators will insist that a company representative sign a statement or affidavit. You have no legal obligation to do so. Develop a policy that states you will neither sign nor acknowledge any written statements presented by FDA Investigators.

□ Identify an Appropriate “On Call” FDA Lawyer: Long before your next FDA inspection, you should add an FDA lawyer familiar with the Inspection process to the company’s emergency contact list who can be notified and remain “on call” once the inspection begins. This person can serve as a useful resource to help quickly answer any difficult regulatory or investigator-related questions that arise during the inspection.

□ Conduct a Mock FDA Inspection: One of the best ways to prepare for a visit from FDA is to conduct a mock inspection. FDA consultants and/or lawyers can visit your facility and play the role of the FDA Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.



When the day comes, the FDA Investigators will arrive unannounced. The FDA Investigators will present their credentials and ask to conduct an entrance meeting. During this meeting, the FDA Investigators will detail how they plan to conduct the inspection, how long the anticipate the inspection will last, and the specific tasks they intend to accomplish. These tasks will typically include the following:

(1) a facility inspection, during which the FDA Investigators will tour and carefully inspect the processing and other areas of the facility;

(2) a records review, during which the FDA Investigators will carefully scrutinize the company’s written food safety programs, and at least three months of monitoring and verification records; and

(3) a swab-a-thon, during which the FDA investigators will collect approximately 100 to 200 microbiological samples from: (a) incoming ingredients; (b) outgoing finished products, and (c) Zone 1, Zone 2, Zone 3 and Zone 4 environments.

The entire inspection process will usually take a few days and, in some cases, can last weeks. Once the inspection begins, use the following checklist to help appropriately navigate the inspection process.

□ Attempt to Negotiate the Areas Being Sampled: During the entrance meeting, the FDA Investigators will typically disclose the types of ingredients, products and/or environmental areas they intend to sample. Attempt to negotiate with the agency to limit the amounts, types or overall focus of the sampling in such a way that, if any results are positive, you can limit to the greatest extent possible the scope of any recall.

□ Carefully Document the Areas Being Sampled by FDA: While the FDA Investigators are conducting their sampling, be sure to carefully document the exact areas from which the FDA Investigators are collecting their samples. In addition, be sure to appropriately characterize the areas being sampled by the agency as Zone 1, Zone 2, Zone 3, or Zone 4. This information will be critical in the event that any samples are positive to determine the most appropriate response.

□ Carefully Consider Whether to Collect “Companion Samples”: In some instances when a company collects companion samples, the samples that the FDA collects test negative while the companion samples test positive. Because taking companion samples doubles the chances that a positive will be found (whether because of the presence of actual contamination or lab error) we generally do not recommend taking companion samples. With that said, be sure to consult with legal counsel because there may be some limited circumstances where companion sampling would be advisable.

□ Hold any Product that FDA Samples: In the event FDA collects finished product samples to test for the presence of Listeria Monocytogenes, Salmonella or any other pathogens, be sure to hold any products produced from the same lot or batch, or any products produced using the same ingredients, until the FDA results come back. If any results are positive, and the product has been held, a recall will not be necessary.

□ Hold any Product from any Lines that FDA Samples: In the event FDA collects any Zone 1 samples from any processing lines, be sure to hold the products that were produced during the periods that FDA was sampling until the FDA results come back. Here too, if any results are positive, and the product has been held, a recall will not be necessary. To provide additional protection, the company may also consider holding any product processed on equipment where Zone 2 samples were collected as well.

□ Aggressively Clean and Sanitize all Areas Sampled by FDA: As soon as possible after FDA has completed its sampling, be sure to aggressively clean and sanitize each of the areas that the agency sampled. This is because, in the event any sample is positive, you will be able to argue that whatever contamination existed at the time of sampling was eliminated and thus could not have affected any additional production.

□ Correct all FDA Observations Immediately: During the course of the inspection, the FDA Investigators will likely share their findings and observations with the DI. Wherever possible, make sure to immediately correct to the satisfaction of the FDA Investigators any observations that are critical of the company. Doing so will demonstrate that the company is committed to quickly resolving any concerns, and the FDA Investigators may choose not to record those observations in the final FDA Form 483.

□ Know What Records FDA is Permitted to Review: FDA has very broad powers to access records. Generally speaking, FDA will be able to review a company’s written food safety programs and related records. The agency is not entitled, however, to review or copy any recipes, financial data, pricing data, personal data (other than to ensure that the company’s employees have received training appropriate to their position and responsibilities), research data, and sales data (other than shipment information).

□ Protect the Confidentiality of any Records FDA Copies: If FDA requests copies of any records the company deems confidential, be sure to mark those records with the following statement: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN CONSTITUTES TRADE SECRET, CONFIDENTIAL AND PROPRIETARY COMMERCIAL INFORMATION PURSUANT TO 5 U.S.C. 552(b)(4), AND SHALL BE STRICTLY PROTECTED AS SUCH FROM ANY DISSEMINATION AND/OR DISCLOSURE. This will put the agency on notice that the information must be protected and may not be disseminated publicly.

□ Do Not Leave the FDA Investigators Unaccompanied: Make sure that while the FDA Investigators are in your facility they remain accompanied. This way, the DI can observe and document the actions of the FDA Inspectors, and respond immediately to any concerns. Additionally, if a company employee remains present at all times, the FDA Investigators will be less inclined to develop or discuss additional “unplanned” inspection “strategies” or “goals” with each other during the course of the inspection.

□ Do Not Sign Any Statements of Affidavits: At the conclusion of the inspection, the FDA investigators may ask you or your employees to author or sign a statement or affidavit describing the inspection, the observations and/or the conclusions. Do not sign, correct or acknowledge any documents, as you have no legal obligation to do so. If such a request is made, consult with your FDA lawyer immediately.



Once the FDA Investigators have finished with their assigned tasks, they will conduct an exit interview and share their findings, observations and conclusions. In most cases, where violations have been identified, the FDA Investigators will issue a FORM 483, which details the specific violations observed by the FDA Investigators. In some cases, depending upon the nature of the observations and conclusions, the FDA Investigators may also ask the company to consider a recall of certain products. The following checklist can be used to help navigate the aftermath of the FDA inspection and bring all issues to closure.

□ If FDA Issues a FORM 483, Prepare a Written Response: During the exit interview, the FDA Investigators will likely present their observations, findings and conclusions. In most cases, any regulatory or food safety violations will be documented in an FDA FORM 483. Although a response is not required by law, a company is generally expected to provide a written response within 15 business days. If the written response adequately addresses FDA’s concerns, FDA will not pursue further regulatory action. If the response is inadequate, however, the agency may issue a “Warning Letter” threatening to withdraw the company’s registration and prevent it from producing product.

□ Support Your Written Response with Documentation: When FDA issues a FORM 483 or “Warning Letter,” make sure your response is appropriately supported with adequate documentation. For instance, FDA will not be satisfied if you simply state in your response that you corrected a problem that the FDA Investigators observed by “conducting additional employee training.” Rather, in addition to stating that you completed the training, FDA will expect you to attach a training log or other document to your response which provides evidencing that the training was, in fact, completed.

□ If FDA Suggests a Recall, Consult Your FDA Counsel: Sometimes the FDA Investigators will observe conditions they believe warrant a recall. The decision whether to announce a recall in the first instance, and any determinations regarding the scope of any such recall, can vary greatly depending upon the facts and data. Any recall decisions should thus be made very carefully, and only after consultation with an experienced FDA compliance attorney. Many companies have successfully convinced FDA, based upon the availability of supporting facts, forensic analysis and scientific data, that the agency is incorrect and a recall is not needed, or the scope can be significantly limited.

Although there are countless variables which will ultimately affect the way in which your next FDA inspection unfolds, the information provided within this FDA Inspection Checklist is designed to provide some of the tools you will need to deal with the most common scenarios. We truly hope that you will find these checklists useful as you prepare for and manage your next FDA Inspection.

About the Author: Shawn Stevens is a food safety consultant and lawyer, and the founding member of Food Industry Counsel LLC, the only law firm in the world that represents the food industry exclusively. Mr. Stevens works throughout the country and abroad with food industry clients (including the world’s largest growers, food processors, national restaurant chains, and food distributors and grocery chains) helping them protect their brand by complying with FDA and USDA food safety regulations, managing recalls, and defending high-profile foodborne illness claims. Additional information about Mr. Stevens’ legal and consulting practice can be found at:


How to Prepare a New Cleaning Tool for Use

New cleaning tools—especially those sealed in plastic pouches like the ones from Vikan and Remco—often look like they’re ready for use right out of the bag. It’s easy to assume these tools can start sweeping, mopping, and brushing right away, however, as most in the food industry know, looking clean isn’t the same as actually being clean. Here are a few steps that must be taken to ensure all new tools are ready for use in food production plants:

  1. Remove any labels

Vikan and Remco both apply labels directly to some of their products, as do many other cleaning tool manufacturers and distributors. Ideally, these labels will peel off easily, especially when they’re dry. If there’s a problem removing a label or there’s residual stickiness, simply use a washrag with warm water and soap, or use a sponge soaked in vinegar to remove the label and any adhesive left behind. It’s easier to peel labels when they’re dry, but a little extra effort may be needed for particularly stubborn adhesives. It’s essential to remove the label and adhesive fully, as the sticky residue can be a trap for debris and bacteria.

  1. Clean the tool

New tools may seem clean, but they’re produced in factory environments that do not have the same rigorous sanitation requirements as food manufacturing facilities. Put new tools through an industrial dishwasher or hand wash them, depending on what the plant’s HACCP plans call for during the tool’s regular usage. Either cleaning option may help remove any remaining label residue, along with preparing the tool for its first use. Don’t make the mistake of assuming a broom or a squeegee that will be used in a low-risk environment is “clean enough” when it comes out of the package. The tool should still be cleaned.

  1. Sanitize for high-risk conditions

To decide how clean a tool should be before use, follow HACCP plans for how they’ll be cleaned during their regular usage. If a tool will be used in a high-risk environment, it should be sterilized before its first use, ensuring any microbes that may have contaminated the item before it arrived to you are fully destroyed. If a tool is going to be used in a low or medium-risk facility, simply cleaning and sanitizing the tool should be enough for it to be used safely.  

  1. Dry the tool

No tool is clean without having been dried first. Whether by hanging it or by putting it through an industrial dishwasher’s drying cycle, tools must be dry to be considered clean. This helps prevent mold and other microorganism growth and ensures the tool is ready for use.

Once these steps are complete, the tools are ready for their designed purposes in food processing plants. Remember to maintain tools by keeping them free of debris and cleaning them frequently. Regular maintenance—starting with these first steps—will keep tools hygienic and help them last longer.

See the Many Colors of Remco at IPPE

We’ll be showing all our true, bright colors at IPPE from 1/31-2/2 in Atlanta! Our experts will be on-hand to talk about the value of color-coding your operations and how our hygienically designed tools are different. You’ll also be able to see our nine distinct colors on some of our most popular Remco and Vikan tools. From orange to purple, and from yellow to pink, we can help you make your organization safer and more colorful.

Color coding can be used to:

1. Provide zone control. Different colors can be assigned to each step in the process, or by manufacturing lines. In the meat industry, many choose to use red tools in the raw prep areas and white for finished products. This is also useful for protecting against allergen cross-contact and can be an important part of an HACCP plan.

2. Increase traceability. When colors are assigned to zones, confirming that a tool is misplaced is easy, and tracing it back to its point of origination is quick. This level of traceability can translate to the prevention of costly recalls.

3. Divide workspaces. For example, red could be used by first shift, while blue could indicate second shift. Using color-coding to designate workspaces in this way can be particularly helpful to companies that closely monitor tool and equipment costs. The result can be a reduced incidence or misuse of tools in unapproved areas, as well as fewer lost or misplaced items.

4. Facilitate 5S Systems. This system works by promoting five pillars: sort, set in order, shine, standardize and sustain. If followed, a workplace should be completely organized at all times. The 5S System recommends integrating color cues throughout a work process or facility in order to reduce waste and optimize productivity. The color-coding promotes a workplace culture where tools and supplies are placed where they are needed and are well-maintained for longevity of use. Color-coded tools intuitively complement and support the goals of a 5S workplace.

5. Separate cleaning and sanitation. Black is commonly used to identify cleaning tools used on floors and around drains. Other colors can designate tools that are appropriate for sanitizing food contact surfaces, or to differentiate among tools that are specified for use with particular chemical agents. This can also help prevent using a powerful cleaner on the wrong equipment.

Remco representatives will be happy to answer all your color-coding questions at IPPE, as well as help you determine if it’s the right choice for your facility. We will have products on display, and we’ll proudly tell you what makes our hygienically designed, color-coded tools unique within the industry. If you’re unable to attend IPPE or you have questions before the show, please contact our customer service representatives here.