If FDA Knocks, Are You Ready to Answer?

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Jon Speer, Managing Partner, Creo Quality, LLC

If I look back over the past couple years of business, I notice a common theme from client engagements: addressing FDA-related non-compliance issues. Sure, maybe this is to be expected since our business focuses on the medical device industry. Regulatory compliance is the name of the game and in our wheelhouse of services and expertise.

But I continue to be a little surprised by some of these engagements and how little the client companies are prepared in case the FDA comes for a visit.

If you are a medical device company (or other company regulated by FDA), you should ALWAYS be prepared for visit from FDA. Technically, FDA is supposed to conduct site inspections of registered companies every couple of years. And if you happen to have product issues, expect the nature of the inspection to be quite a bit more stringent.

What can you do to prepare for a FDA inspection?

  • Conduct internal audits of your processes per Quality System Regulations (which you should be doing any way).
  • Bring in an objective third party at least once a year to thoroughly audit your processes and procedures against FDA regulations.
  • Conduct management reviews annually (and I suggest semi-annually). Be critical of complaint handling, CAPA, supplier management, risk management, document control / record management, and design control processes. Be sure these processes are appropriately linked so that data from one process feeds the others.
  • Be overly conservative in decision-making processes.
  • Consider patient and end-user safety first.
  • Follow your own procedures.

Yes, if your company has adequately defined processes and procedures according to FDA regulations and you follow them, you should always be ready for a FDA inspection.

Make sure to follow Jon Speer (@creoquality) on Twitter. He may also be reached via email.

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