FDA Inspection Checklist

Remco Products is proud to present the FDA Inspection Checklist from Food Industry Counsel as part of our ongoing effort to deliver valuable and up-to-date information to the food industry. We are not legal experts and do not provide legal advice. For any legal matters, please consult with a qualified attorney. You can also reach out to Shawn Stevens, the author of this post, at  .

How to Prepare for, Handle, and Follow Up on an FDA Inspection

Food Industry Counsel, LLC is excited to offer one of the most detailed and practical FDA Inspection Checklists available. With the implementation of the Food Safety Modernization Act (FSMA), the FDA has taken on a more active role in ensuring the safety of the U.S. food supply. As new regulations come into effect, the agency is now conducting more rigorous inspections than ever before. In the coming years, every food facility in the country will be subject to an on-site inspection by the FDA.

Here’s what you should expect during an unannounced FDA inspection:

• Review of Written Food Safety Programs: FDA inspectors will closely examine your company’s written food safety programs and verification records to ensure they meet FSMA requirements.
• Microbiological Sampling: Inspectors will collect samples from different zones within the facility to check for pathogens like Listeria and Salmonella.
• Recall Requirements: If testing shows contamination levels exceed thresholds, the FDA may require a recall.
• DNA Matching: The FDA will compare pathogen DNA found in your facility with the CDC's PulseNet database to detect matches and initiate recalls if necessary.
• Criminal Investigations: In cases where contaminated products have caused illness, the FDA may launch broader investigations, including criminal ones.

To help you manage the process effectively, we’ve created a comprehensive checklist that covers everything from preparation to post-inspection actions. These steps will help you stay compliant, avoid unnecessary recalls, and maintain a strong relationship with regulatory authorities.

Preparing for the Inspection

Before the FDA arrives, make sure you complete these key tasks:

• Set Up a Meeting Space: Choose a quiet room where the FDA can review documents without accessing sensitive files.
• Assign a Designated Individual: Ensure there is always someone available to communicate with the FDA during the inspection.
• Complete PCQI Training: At least one team member should have received Preventive Control Qualified Individual training.
• Finalize Your Food Safety Systems: Make sure all plans—like GMPs, Sanitation Programs, and Recall Plans—are up to date.
• Organize Records: Keep the last three months of records easily accessible for quick retrieval.
• Document Corrective Actions: Always explain the root cause and how it was resolved.
• Upgrade Equipment: Ensure sanitation tools like flashlights are powerful enough to match FDA standards.
• Review Allergen Controls: Accurate labels and strict cross-contact prevention are crucial.
• Conduct Environmental Monitoring: Implement a program if you handle ready-to-eat foods.
• Simulate the Inspection: Do a mock inspection to identify and fix potential issues beforehand.

During the Inspection

Once the FDA is on site, follow these guidelines:

• Negotiate Sampling Areas: Try to limit the scope of sampling to minimize recall risks.
• Document Sampling Locations: Keep track of which areas were tested and their zone classifications.
• Decide on Companion Samples: Be cautious about collecting them, as they increase the risk of positive results.
• Hold Sampled Products: Keep related batches or ingredients in storage until test results are known.
• Clean After Sampling: Immediately sanitize sampled areas to show proactive measures.
• Correct Observations: Address any concerns right away to prevent them from being noted in the final report.
• Protect Confidential Records: Label sensitive documents clearly to prevent public disclosure.
• Stay with the FDA: Never leave them unattended to monitor their activities.
• Refuse to Sign Documents: You are not legally required to sign any statements or affidavits.

After the Inspection

Once the inspection is over, take the following steps:

• Respond to Form 483: Provide a timely and well-documented response to address any findings.
• Support Your Response with Evidence: Include logs, reports, and other documentation to back up your claims.
• Consult Legal Counsel Before a Recall: A recall decision should never be made without expert guidance.

The FDA inspection process can be complex, but with proper preparation and the right strategies, you can navigate it confidently. This checklist is designed to help you deal with common challenges and protect your business from unnecessary regulatory action.

About the Author: Shawn Stevens is a food safety consultant and attorney who founded Food Industry Counsel, LLC—a unique law firm dedicated solely to representing the food industry. He works with major growers, processors, restaurants, and distributors across the U.S. and internationally, helping them comply with FDA and USDA regulations, manage recalls, and defend against foodborne illness claims. Learn more about his work at www.foodindustrycounsel.com.