Preparing for An FDA Inspection

The Food and Drug Administration (FDA) inspects food production facilities to ensure compliance with the law. FDA inspections of human food facilities are primarily focused on whether there are violations of Current Good Manufacturing Practices (cGMPs), unsanitary conditions, preventive controls, and any other issue that could make the food unfit for consumption. FDA inspections are routine and should not be cause for alarm when you have effective food safety processes and plans in place.

Preparing for an FDA inspection

Tips for Being Successful in an FDA Inspection

The reality is that FDA inspections require careful planning. These tips aren’t all-encompassing, but they’re a great jumping-off point and will give you an idea of how to be successful when the FDA arrives.

  • Understand the step-by-step plan for the inspection.

    • Don’t confuse your personnel with long-winded explanations. Keep your instructions brief and clear to avoid confusion. Understanding the step-by-step process will provide you with an overall picture of what to expect from the inspection.
  • Make sure documents are easily accessible.

    • In the best-case scenario an FDA inspection will span days, but it could last months if your documents aren’t on hand. Keeping all relevant documents neatly organized will streamline the process so it doesn’t drag on longer than necessary.
  • Label items requested for review.

    • The investigators performing the inspection will let you know which materials they need to see prior to beginning the review. Label them clearly to make retrieval during the inspection easier. In all likelihood the FDA will also want to review things like marketing materials. Labeling and locating these ahead of can make the process faster.
  • Answer questions clearly and concisely.

    • Honesty is the best policy when it comes to an FDA inspection. Answer questions as openly and honestly as you can, but if you do not know something don’t make up an answer.
  • Report any corrective actions or recalls.

    • Be prepared to provide documentation supporting all your actions when it comes to corrective actions and recalls.
  • Compile recent product complaints.

    • You can almost bet that investigators will ask for complaints and CAPAs that have occurred since your last inspection. Compile them ahead of time to save effort and time during the inspection.
  • Assign designated jobs for before and during the inspection.

    • You may even want to consider running a mock inspection to ensure all personnel are prepared for the pressure of the real thing.
  • Ensure food safety plans and systems are finalized and available.

    • These are certainly items that the FDA is likely to be interested in during their inspection, so you will want to have your final food safety plan ready to share.
  • Review allergen controls.

    • Allergens are a major safety concern that the FDA is on the lookout for; be prepared to discuss your methods for mitigating any risk.
  • Consult environmental monitoring and sampling.

    • The FDA may perform sampling during their inspection to ensure no bacteria is present in the environment and that all products are safe.

The only way to ensure success when it comes to an FDA inspection is to be as prepared as possible, and that means having the right training, safety plan, and PCQI on your team. ImEPIK’s online PCQI training covers industry-specific scenarios, test learners’ knowledge, and offers entirely self-paced online training.

Purchase training for your PCQI now, and leave nothing up to chance when it comes time for you next FDA inspection.

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