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