FDA Inspection Checklist

Remco Products is proud to introduce the FDA Inspection Checklist from Food Industry Counsel as part of our ongoing effort to provide valuable insights to the food industry. We do not offer legal advice or endorse any legal services. For legal support, please consult your attorney. You can also reach out to Shawn Stevens, the author of this guide, for more information.

How to Prepare, Respond, and Recover from an FDA Inspection

With the implementation of the Food Safety Modernization Act (FSMA), the FDA has taken a stronger role in ensuring food safety across the United States. As a result, inspections have become more rigorous, and the agency is now conducting unannounced visits with greater frequency. The goal is to ensure that all food facilities are following strict safety protocols. Here's how you can prepare for and manage the process effectively.

During an FDA inspection, investigators will focus on several key areas: reviewing your written food safety programs, collecting microbiological samples from different zones within your facility, and comparing these samples against the CDC’s PulseNet database. If pathogens like Listeria or Salmonella are detected, recalls may be required. In severe cases, criminal investigations could follow if illness is linked to your products.

To help you stay ahead of these challenges, we’ve compiled a detailed checklist covering what to do before, during, and after your next FDA inspection. This guide is designed to help you maintain compliance and avoid unnecessary regulatory issues.

Preparation Steps Before the Inspection

Before the FDA arrives, make sure you have a designated meeting space free of sensitive records. Assign two individuals to act as your primary and secondary contacts for the inspection. Ensure they are trained in preventive controls and familiar with your food safety plans. Organize your records so they can be quickly accessed, and document all corrective actions properly. Also, review allergen control procedures and conduct environmental sampling to identify potential risks early.

Managing the Inspection Process

When the FDA comes, be prepared to negotiate the areas being sampled, document where samples are taken, and consider whether to collect companion samples. Hold products that are tested until results are known, and clean and sanitize all sampled areas immediately. Make sure the FDA does not access confidential information and never sign any statements unless advised by legal counsel.

After the Inspection

If the FDA issues a Form 483, respond promptly and thoroughly. Support your response with documentation to show that you’ve addressed the concerns. If a recall is suggested, consult your FDA lawyer before making any decisions. Remember, many companies have successfully avoided recalls by providing strong scientific evidence and expert analysis.

While every inspection is unique, this checklist provides essential tools to help you navigate the most common scenarios. Staying proactive and well-prepared can make a big difference in how your inspection goes and what outcomes you face afterward.

About the Author: Shawn Stevens is a leading food safety consultant and attorney who founded Food Industry Counsel LLC. His firm specializes exclusively in food industry compliance, helping companies avoid recalls, manage regulatory challenges, and defend against foodborne illness claims. Learn more about his work at www.foodindustrycounsel.com.