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