FDA 483 Trend #1: FDA plans escalating penalties

In recent times, the FDA has stepped up its actions against pharmaceutical manufacturers, with 483s escalating to warning letters, warning letters to consent decrees far more quickly than it has in the past. What’s more, FDA officials have warned that it might go after individual executives and slap them with charges, which could impact or even end their careers.

Of late, the FDA has warned that it might file charges based on the Park Doctrine, which holds the individuals can be charged with a crime if the agency finds serious corporate malfeasance or neglect in a facility.

A few years ago, the FDA developed guidelines for misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions. Of course, this will not be used often if past application is any indicator. Federal attorneys generally prefer to prosecute felonies, and these are misdemeanor charges at best. While the guidance is still vague in this area, the rhetoric has inarguably increased in recent months. This is an area worth watching.

If the FDA feels the need to raise its voice, it comes after a long history of being taken lightly. According to one blogger, a 30-year industry veteran known as “QA Pharm,” most quality assurance managers in pharmaceutical manufacturing plants just aren’t that scared of a 483 from the FDA any more. (In fact, QA Pharm says that he and his colleagues long ago began thinking of them as a “calling card,” merely a sign the FDA had passed through your gates.)

For more on how the FDA is utilizing the Park Doctrine, read this post from the FDA Law Blog.

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