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