How the Quality Manager Gets Fired aka The $100,000 FDA Compliance Mistake

How the Quality Manager Gets Fired aka The $100,000 FDA Compliance Mistake

March 12th, 2013 // 10:18 pm @

March 12, 2013

It always amazes me. The pharmaceutical industry is full of some of the brightest and most dedicated professionals in any industry anywhere. However, some of the simplest FDA regulations can trip up some very smart people at some very big companies.

The biggest example I can think of is one that our great Webinar speaker Dennis Moore, President, AUK Technical Services, brought up in his March 12 Webinar (rebooked for April 11).

Dennis talked about the new 15 day response time that you have if you get a 483. The big thing to remember on this rule is – FDA MEANS BUSINESS ON THIS! If they do not receive your 483 response within 15 days, you my friend are going to get a warning letter.

Be advised that if you spend $100,000 on some fine FDA regulatory consultants and they craft a wonderful new quality system SOP to fix your 483 observations, it’s all for naught if it is not in FDA’s hands in 15 days. There have indeed been cases where companies spend $50,000 or even $100,000 on their 483 response and it got to FDA on day 18. If that happens, all that money is down the drain. You are out of luck, and if you are the quality manager, you might be the ex-quality manager. Talk about a ‘d’oh!’ moment!

And while it sounds surprising, this sort of thing happens all the time.

Please. Make sure that this disaster does not happen to you. Remember, FDA will NOT even look at your 483 response if they do not have it after 15 days.

If you like that tip, please be sure to check out our rebooked Webinar with Dennis Moore April 11, where you will learn many more interesting tips and tricks for your next inspection.


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