Sunday, February 22, 2009

what is FDA 482 and FDA 484 and other form used in FDA inspection

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

1 comment:

  1. Why should you not sign the receipt FDA 484?