Attention: If you are a medical device company that has a registered class-II or class-III medical device with the United States Food & Drug Administration (FDA), you might come to be inspected by the FDA. Your readiness for an FDA inspection will determine how well your inspection will go. Treat it like an important exam, or your wedding day. You cannot rely on hope, you need to be prepared.
After the inspection is complete, if the inspector finds any issues, they will issue a summary of the issues in FDA Form 483 Inspectional Observations or what’s commonly known as a 483 citation.
You need to treat this with a level of high urgency and quickly establish a timeline to analyze your response. This can mean:
· Identifying the root cause
· Issuing and tracking Corrective And Preventive Actions (CAPA)
· Make changes to your design, or production, or whatever your root cause leads you to identify as a corrective action.
· Possibly make changes to your Design History File (DHF) or Device Master Record (DMR)
· Constant follow-up and communication with the FDA
Needless to say, having a good quality, complaint, non-conformance, and CAPA management system is critical for your company to resolve ta 483 citation effectively. If quality systems and engineering, and regulatory affairs teams are working in silos, that can put additional strain on your ability to respond and resolve a citation.
The 3DEXPERIENCE platform offers License to Cure, an end-to-end solution that medical devices can use to manage a 483 citation or any end-user complaint effectively by eliminating the silos between key processes that need to coordinate well.
Read this whitepaper to see how you can connect the dots between quality, engineering, and regulatory affairs to increase your operational efficiency, complaint, Non-Conformance, & CAPA management, and regulatory submissions.