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Mylan plant slapped with 32-page FDA Form 483

When Mylan recently announced 500 layoffs at its plant in West Virginia, it said the cuts were “consistent to discussions it was having with the FDA.” What it didn’t say was those discussions included problems the FDA uncovered during a five-week-long inspection of the massive plant.
 
It turns out those cuts came just a couple of weeks after the inspection concluded with a 32-page Form 483 (PDF) from the FDA. The agency in 13 observations chastised senior management for poor oversight by the plant’s quality control department, major lapses in equipment cleaning, ineffective laboratory controls and sampling and more.

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