Are we dealing with a new FDA? I posed this question last summer. In the past couple years, CQ has had quite a few engagements to help medical device companies during FDA inspections and to correct FDA 483 and warning letter observations. Data also supports my anecdotal experience as reported in a recent post on the AssurX blog:
- 2005: FDA CDRH inspected 2,304. 2011: 3,369. I’m guessing the number was higher still in 2012
- 2008: CDRH issued 152 warning letters. 2010: 200 issued.
- 2008: CDRH issued ~4,000 483 observations. 2010: ~5,000.
Sometimes we have a chance to engage prior to a FDA inspection. In these situations, the process is usually a little smoother and calmer and a whole lot less stressful. These are the medical device companies who have enough clairvoyance to realize their shortcomings and are interested in developing an action plan to correct issues. These are the medical device companies who are doing their best to prepare for a visit by FDA.
And other times we don’t get involved until the FDA inspection is over and 483 observations (and sometimes a warning letter) have been issued. There has been a case or two when a medical device company has reacted with a bit of shock and awe after a FDA inspection. Reactions of real surprise. Sorry – but there really shouldn’t be that much of a surprise after a FDA inspection. Okay, the FDA quality system regulations are not entirely black and white. But the QSR is published–has been for quite some time. And a medical device company should have implemented policies and procedures to address the regulations and be active in keeping company procedures current. However, the companies which are suddenly surprised after the inspection did not do a good job of keeping policies and procedures up to date.
Has it been a while since your medical device company has had a FDA inspection? Don’t think FDA will come visit your company? You might be right. I suggest, though, that you get prepared–just in case.