FDA Inspection Observations: Best Practices for Responding to Them

Q: As we update our internal guidance for responding to an FDA inspection, I have some questions:

1. Is it good practice for us to submit a written request for the Establishment Inspection Report (EIR) after the FDA inspection — or will FDA automatically provide us with a copy?
2. If we do submit a written request for the EIR, should we reference the Freedom of Information Act?
3. Is 10 days a reasonable time for us to send our initial response to FDA after we receive a 483 inspection observation?

A: The Agency should provide you with a copy of the EIR when it decides the FDA inspection is closed (no 483s or at least no substantive 483 observations). If you do not receive the EIR within 60 days of the close of the inspection, I would submit a request under the Freedom of Information Act.

FDA now has a policy to review any responses submitted within 15 working days after the inspection close-out.

In answer to your third question, FDA now has a policy to review any responses submitted within 15 working days after the inspection close-out and to use your response in making its compliance decisions. So yes, I think 10 business days is a reasonable time to target for sending your initial response.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor of FDA’s Investigations Operations Manual) and instructor of EduQuest’s QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality Systems Regulation.

Share

Leave a Reply

Your email address will not be published. Required fields are marked *