FDA Finds Quality Testing Flaws at Wockhardt’s Illinois Plant
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Wockhardt Ltd., the generics drugmaker that has faced quality issues at two of its Indian plants, was cited by the Food and Drug Administration for testing lapses at a factory in Illinois.
The FDA issued a Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wochardt’s drugmaking facility in Morton Grove, Illinois, over seventeen days between January and March, according to a document on the agency’s website.