Q: I’m preparing a plan for what to do when an inspector shows up at our site for our next FDA inspection, including who will be the contact person, what information to give the inspector at the start of the inspection,…
Tag Archive for EIR
Internal Audit Reports: Best Practices for Shielding Findings from FDA Eyes
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Q: My company has an SOP that defines which documents are considered Non-Disclosure Information. The SOP includes findings in our internal audit reports. Does FDA have the right to see these confidential documents anyway? A: We get this question frequently, and the…
483 Response: What to Include in Your Letter to FDA
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Q: When we prepare a 483 response letter to an FDA notice of inspectional observations, do you recommend we include supporting documents such as SOPs and training records — even those we’ve already shared with the on-site FDA inspector?A: Yes, and here’s the…
FDA Inspection Observations: Best Practices for Responding to Them
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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 —…