Avoiding FDA 483s Strategy #6: Don’t make the FDA have to tell you a dozen times

Abbott Nutrition was cited a few years ago for failing to exclude pests from processing areas. This was the plant’s 31st citation related to warehouse beetle infestations since 2007.

This one may seem obvious, but since it comes up repeatedly in the 483 batch from 2012, let’s say it again. If the FDA cited you in the past, letting the same conditions stay in place is asking for trouble. Big trouble.

While it may have had a more lax attitude in the past, today the agency has very little patience for repeat violations, a message that’s coming all the way down from Commissioner Margaret Hamburg.

At minimum, be sure that you don’t get hit with 483s citing the same issues two times in a row. And if you’re a multi-facility organization, make sure that all of your sites get whatever message the inspector sent with the citation.

By the way, if you’re ready to fix a problem, make sure it’s really fixed, not dismissed with a workaround. “Slapping on a band aid is very short-sighted, and it will get you in trouble,” says a veteran FDA attorney. “The agency is not in a mood to talk and isn’t going to forgive easily.” At that point, you could be steps away from a warning letter, and things only get uglier from there.

Other 483 Resources

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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