FDA Inspection Checklist

May 30 10:33:02, 2025

Certainly! Below is the rewritten content in English: --- As a company dedicated to providing valuable insights to the food industry, Remco Products is proud to share Food Industry Counsel’s FDA Inspection Checklist. Please note that we do not endorse any legal services or offer legal advice. For legal matters, please consult your attorney. You can also reach out to Shawn Stevens, the author of this post, directly. --- ### Preparing for Your Next FDA Inspection Food Industry Counsel, LLC is pleased to offer you the most comprehensive and practical FDA Inspection Checklist available. Following the enactment of the Food Safety Modernization Act (FSMA), the FDA has been tasked with modernizing the safety of the nation's food supply. New FSMA regulations are now being enforced by the FDA during routine inspections. Over the next few years, every food facility in the U.S. will undergo an on-site inspection. Here are the FDA's key priorities during these routine, unannounced visits: 1. Thoroughly reviewing each company's written food safety programs and verification records to ensure compliance with FSMA requirements. 2. Conducting extensive microbiological sampling across Zones 1 through 4 within food facilities to detect potential pathogenic contamination. 3. Requiring recalls if the percentage of positive tests for Listeria monocytogenes, Salmonella, or other pathogens exceeds FDA thresholds. 4. Matching the DNA fingerprints of any pathogens found in the facility against the CDC’s PulseNet database (which contains over 1 million human isolates) to identify any matches, leading to product recalls if matches are found. 5. Initiating broader investigations, including criminal ones, against food companies whose products are linked to human illnesses. Given this context, all companies should start preparing for their next FDA inspection. To ensure a successful inspection, use the following checklists to ensure you’ve prepared adequately before the inspectors arrive, to handle the inspection process smoothly once it begins, and to address any FDA critiques afterward. --- ### Preparing in Advance for Your Next FDA Inspection #### Pre-Inspection Checklist Much of the groundwork for a successful inspection should be completed well before the FDA inspectors arrive. Every company should begin working immediately to achieve the following critical tasks: - **Designate a Meeting Space:** Choose a suitable area within your facility to host the FDA inspectors when they arrive. This could be a conference room or an empty office with enough desk space for reviewing records. Ensure this space is free of any records—whether in binders, boxes, or on computers—that inspectors could access unsupervised. - **Assign Designated Individuals:** Appoint a primary and secondary Designated Individual (DI) for each facility to act as the main point of contact with the FDA inspectors. Coordinate vacation schedules to guarantee that at least one DI is always available. - **Complete PCQI Training:** Ensure the primary DI has undergone Preventive Control Qualified Individual (PCQI) training. While not mandatory under FDA regulations, inspectors will likely expect at least one employee to have completed this training. - **Finalize Written Food Safety Systems:** Confirm that your company’s written food safety systems are complete and that the primary and secondary DIs are familiar with all aspects of these plans. Depending on the size of your business and the nature of your products, this may include Good Manufacturing Practices (GMPs), Sanitation Programs, Preventive Control Plans, Recall Plans, Environmental Monitoring Programs, Foreign Supplier Verification Plans, Sanitary Transportation Plans, Food Defense Plans, and Produce Safety Plans. - **Organize Records for Easy Access:** Ensure that supporting records for each program are organized and easily retrievable so the DI can quickly provide the past three months of records for inspection. Although FDA requires most records to be kept for at least two years, inspectors typically request only the previous three months. - **Document Corrective Actions Properly:** If deviations occur, ensure you document corrective actions correctly. Each corrective action should identify the root cause, steps taken to prevent recurrence, and, if applicable, a written conclusion (supported by factual and scientific data) stating that the deviation “does not create an immediate food safety issue.” - **Upgrade Sanitation Equipment:** Replace outdated or underpowered flashlights used by sanitation staff with high-powered models similar to those used by FDA inspectors. This ensures your team can thoroughly clean areas that inspectors will highlight. - **Review Allergen Controls:** FDA is increasingly requiring recalls if inspectors find inadequate allergen controls during their visual inspections. Verify that your ingredient labels are accurate and that cross-contamination risks are minimized. - **Conduct Environmental Monitoring:** If you process ready-to-eat foods exposed to the environment before packaging, develop and implement an environmental monitoring program before inspectors arrive. - **Conduct Environmental Sampling:** Since FDA will collect up to 200 microbiological samples, conduct your own swabbing to identify and fix any hidden issues. If done correctly, with legal counsel, these results can remain confidential. - **Develop a Microbiological Sample Retain Policy:** If your lab retains isolates or testing materials indefinitely, establish a policy requiring disposal within 24 hours of testing. - **Develop a Companion Sample Policy:** If you decide to collect companion samples alongside FDA samples, ensure there’s a clear policy for handling, testing, and discarding them. - **Develop a “No Photography” Policy:** If FDA insists on taking photos, leverage your corporate policy to prevent it. - **Develop a “Do Not Sign” Policy:** Inspectors may ask you to sign statements or affidavits. Remember, you’re not legally obligated to do so. - **Identify an On-Call FDA Lawyer:** Add an FDA lawyer familiar with inspections to your emergency contacts list. They can assist with regulatory questions during the inspection. - **Conduct a Mock Inspection:** Simulate an FDA visit with consultants or lawyers to identify gaps and improve your programs. --- ### Managing the Actual FDA Inspection #### Inspection Checklist When the inspectors arrive unannounced, they’ll present credentials and request an entrance meeting. During this session, they’ll outline their plans, anticipated duration, and specific objectives. These often include: 1. A facility inspection, where inspectors tour and meticulously examine processing and other areas. 2. A records review, where inspectors scrutinize written food safety programs and at least three months of monitoring and verification records. 3. A swab-a-thon, where inspectors collect 100 to 200 microbiological samples from incoming ingredients, outgoing finished products, and Zones 1 through 4. The entire process usually takes a few days, sometimes longer. Use the following checklist during the inspection: - **Negotiate Sample Scope:** Try to limit the types and amounts of samples to minimize recall risks if results are positive. - **Document Sample Locations:** Record the exact locations of samples and categorize them as Zone 1, 2, 3, or 4. - **Consider Companion Samples Wisely:** While generally discouraged, consult legal counsel to assess limited situations where companion sampling may be beneficial. - **Hold Sampled Products:** If FDA samples finished products, hold batches or ingredients until results return. - **Aggressively Clean Sampled Areas:** After sampling, thoroughly clean and sanitize inspected areas to show any contamination was eliminated. - **Correct Immediate Issues:** Address any critical observations promptly to show commitment to resolution. - **Limit Record Access:** Understand FDA’s access rights but protect sensitive information by marking confidential documents accordingly. - **Accompany Inspectors:** Ensure inspectors remain accompanied to monitor their actions and respond to concerns. - **Avoid Signing Documents:** Refrain from signing statements or affidavits unless advised by legal counsel. --- ### Managing the Aftermath of an FDA Inspection #### Post-Inspection Checklist After the inspection concludes, inspectors will conduct an exit interview to share findings. In most cases, violations will be noted on an FDA Form 483. Follow this checklist to address any issues: - **Prepare a Written Response:** If a Form 483 is issued, draft a response addressing concerns within 15 business days. - **Support Responses with Documentation:** Provide evidence for corrective actions, such as training logs. - **Consult Legal Counsel on Recalls:** If inspectors suggest a recall, seek expert advice to assess necessity and scope. This checklist equips you with tools to handle common scenarios. We hope it proves useful in preparing for your next FDA inspection. --- About the Author: Shawn Stevens is a food safety consultant and lawyer, and founder of Food Industry Counsel LLC, the sole law firm representing the food industry exclusively. He advises clients globally on FDA and USDA compliance, recalls, and litigation. Learn more at [www.foodindustrycounsel.com](http://www.foodindustrycounsel.com). --- Let me know if you'd like further adjustments!

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