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The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility. Read More
A Pennsville, New Jersey API manufacturer earned itself a Form 483 for quality violations at its facility, including failure to reject faulty drug substances and inadequate investigations of discrepancies. Read More
The FDA hit Bensenville, Illinois-based Empire Distributors with a warning letter for selling an unapproved new drug product containing the active ingredients for FDA-approved erectile dysfunction drugs. Read More