During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $400,000 down the drain.

Has it been a few years since your last inspection? You know an FDA inspection will happen. An FDA inspector could call tomorrow and announce plans to visit your facility next week. Would you be prepared? What do you need to do to get ready?

I don’t have all the answers, but I’ve been through more than a few FDA inspections. With that in mind, I’d like to share five tips to help your medical device company get ready for an FDA inspection.

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