Top 5 Tips for a Successful FDA Inspection:

✅ Top 5 Tips

1. Be Inspection-Ready Always – Maintain compliance at all times, not just when expecting an inspection. Ensure documentation, training records, SOPs, and facilities are always up-to-date.

2. Ensure Documentation Accuracy – Follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available). Inspectors give more importance to data integrity.

3. Train Employees – Conduct mock audits and train staff on how to interact with FDA inspectors (answer truthfully, clearly, and within their knowledge scope).

4. Maintain Clear Communication – Designate a point person (inspection coordinator) to communicate with FDA investigators and ensure responses are consistent and professional.

5. Respond Correctly & Promptly – If issues are identified, address them immediately during the inspection where possible, and ensure timely corrective actions post-inspection.

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