Forms Commonly Used During FDA Inspections
FDA 482 – Notice of of Inspection
FDA 483 – List of Observations
FDA 484 – Receipt for Samples
FDA 463 – Affidavit
Special purpose affidavits
Various special purpose forms
EIR – Establishment Inspection Report
FDA 482 – called Notice of inspection
- FDA Investigators must formally identify themselves by presenting credentials
- FDA issues a FDA 482- to Inspection Coordinator/Executive Manager
- A copy shall be obtained for the Inspection File
- Firm can not copy FDA credentials
FDA 484- Request for Samples
FDA inspectors can collect samples from the site but they have to issue a receipt of samples.
Items not requiring a FDA 484
- Items or Materials Examined but not removed
- Labels or Promotional Material
- Photographs
- Records