FDA Inspections

Are You Ready for an FDA Inspection?  

(Hint: An FDA inspection is very different from a registrar’s QMS audit.)

An FDA inspection can be nerve-wracking—especially if it’s your first.  Are you prepared?  Are employees trained?

Do you have a written procedure that addresses the following?

  • Types of FDA inspections (i.e., For Cause, Compliance Follow up, Routine)
  • Preparing for the Inspection (Responsibilities and Logistics)
  • The inspection process:
      • Initial communication by FDA
      • Presentation of Form 482 (Notice of Inspection)
      • Interaction with the investigator and conduct during the inspection
      • What to do if an affadavit is presented
      • Records FDA cannot review
      • Issuance of Form 483 (Notice of Inspectional Observations)
      • Establishment Inspection Report (issued post-inspection)

Advanced Quality System Solutions can assist medical device companies with all aspects of an Inspection including: 

  • FDA Inspection procedure and employee training (Practical Dos and Don’ts)
  • FDA Inspection preparation and on-site support
  • Written responses to FDA for 483s and Warning Letters and initiation of related corrective actions