Picture this: you’re sipping your morning coffee, catching up on emails, and suddenly, an FDA inspector is at your door. Surprise! If you’re in FDA regulated industries, this could be a reality. While the idea of an FDA inspector showing up unannounced might make your heart race, don’t worry—you can handle it!

Here are some top tips to help you manage an FDA inspection like a pro and ensure your company stays compliant.

1. Stay Calm and Channel Your Inner Zen:

When an FDA inspector arrives unannounced for an FDA inspection, it’s easy to let your nerves get the best of you. But remember, they’re just doing their job to ensure your business complies with FDA regulations. Take a deep breath, greet them with a smile (or at least a non-panicked expression), and politely ask to see their credentials. Always verify FDA inspector credentials before proceeding with the inspection.

2. Sound the Alarm—But in a Calm, Controlled Way:

Once you’ve verified the inspector’s credentials, it’s time to notify key personnel about the FDA audit. Get your compliance officer, legal counsel, and senior management in the loop ASAP. They need to know what’s happening and be ready to step in if needed to ensure your FDA compliance measures are in place.

3. Assign a Tour Guide:

Designate someone from your team as the main point of contact for the FDA inspector. This person should be well-versed in your operations and FDA compliance protocols. They’ll answer questions, provide documents, and ensure the FDA audit stays on track.

4. Honesty is Key—But Keep It Tight:

When it comes to an FDA inspection, honesty really is the best policy. But that doesn’t mean you need to overshare. FDA inspectors are trained to be friendly so that they can gather as much information as possible. Know that they might be friendly, but they are not your friends. Stick to what’s asked for, and avoid volunteering extra information. Oversharing can turn a simple FDA audit into a full-blown investigation.

5. Keep a Paper Trail:

Document everything during the FDA inspection. And I mean everything. From the inspector’s questions to the documents you hand over, keep a detailed record of the entire FDA audit process. This will be your safety net if there are any follow-up questions or discrepancies later on.

6. Start Addressing the Observations:

There are some observations that can be dealt with in the moment. If they see something like a spill in a manufacturing area, you can clean it up and mention to them that it has been handled. This will keep one less observation for them to note later in the form 483.

7. Take Notes on the Critique:

At the end of the FDA inspection, the inspector will likely discuss any issues they found. This is your chance to listen carefully, take notes, and ask for clarification if needed. Once they leave, gather your team, review the observations, and start planning how to address any problems to maintain FDA compliance.

8. Expect the Unexpected:

An unannounced FDA audit could lead to the issuance of follow-up inspections or additional requests for information. The best way to avoid future surprises is to keep your compliance efforts strong. Regular internal audits and ongoing improvements are essential to staying prepared for any FDA inspection. Make sure you are leaning into mock FDA inspections on a regular basis to make sure you and your team are ready.

Conclusion

An unannounced FDA inspection might not be on your list of favorite things, but with the right approach, it doesn’t have to be a nightmare. Don’t hesitate to reach out for help in preparing for an FDA audit or handling an unannounced one.

By staying calm and being prepared, you can navigate the FDA audit process with confidence. The goal is to show the FDA that your business is compliant and committed to safety. And who knows? You might even learn something valuable along the way!