Help! My FDA Inspection (or Quality Audit) is 48 hours away – What is the bare minimum that I should do?

Not everyone has the luxury of preparing for an FDA Inspection or Quality Audit well in advance. Here are a few things you can do to prepare for an internal or external audit with very little notice.

  1. Assign an Audit Host, Tour Guide, and Backroom Support Lead
  2. Training. Make sure there is no overdue training. Run a query or have all employees review their current training.
  3. Pull Complaints and CAPAs for the last 2 years
  4. Tour Route and SME prep (This is critical!)
  5. If you have had any recalls in the past 2 years, dust off these files
  6. Pull documents and records in advance of the audit
    • Organizational Chart
    • Quality Manual
    • Quality policy
    • SOPs
    • Training
    • Complaints and CAPAs
    • Technical Files / DMF / Product Specifications
    • Facility layout drawing
    • Process flow diagram or material flow diagram
    • Previous FDA Inspection Records
  7. Prepare a demonstration product to show the auditors or FDA Inspectors. Make sure the product(s) are appropriately labeled. (if applicable) Obviously if you are an API manufacturer you WILL NOT be bringing a drum or API into the audit room. Prepare to show the auditor the product in a controlled area.  If you are a device or tablet manufacturer you WILL bring in a finished, labeled product with an over-sticker indicating DEMO PRODUCT, NOT FOR HUMAN USE.
  8. Prepare IFUs and labels to show the auditors, as applicable.  FDA Inspections will require these.
  9. Many auditors require you to show interstate commerce (or shipment to their country) so they may also request shipping records or POs showing the transfer of goods.


Click here to learn more about Inspection Readiness.



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