What are the most common issues during FDA inspections of medical devices?

FDA inspections are par for the course in the medical device industry. Every medical device company class II or higher, in fact, should be inspected at least once every two years, according to existing bylaws.

Every medical device, medical device company and FDA inspection is different, but if you look at the applicable data from 2013 you can see some very clear trends in the most common features of these inspections.

FDA 483 Observational data for 2013 shows that more than 35 percent of the observations involved three areas: Design controls (13.25%), Corrective or Preventative Action (11.75%) and Complaint Handling (10.65%). These statistics are invaluable when it comes to focusing on your next FDA inspection.

To make sure your FDA inspections flow as smoothly as possible, ensure the protocols below are followed:

  • Properly document all design controls. Your lack of thoroughness will not go ignored.
  • Follow the proper corrective and preventive actions when responding to problems. It can be tempting to simply jump in and fix the problem, but moving forward with a controlled approach will pay dividends in the end.
  • Record all complaints. Operating with the “out of sight, out of mind” method can be tempting when dealing with complaints, but fixing the issue without following the proper investigative protocols will lead to future inspection questions.

FDA inspections are a common feature of the medical device industry and something companies should be prepared for every day. Adhering to strict guidelines throughout the year will lead to a smoother inspection process.

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