483
Pharmaceutics International IncFDA 483 - Pharmaceutics International Inc - November 14, 2022
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Record Details
An FDA inspection of Pharmaceutics International Inc in Hunt Valley, MD, revealed significant deficiencies in their drug product manufacturing operations. Observations included inadequate cleaning processes for multi-purpose equipment, failure to properly test components from suppliers, and an insufficient stability program for drug products. These issues indicate a lack of adherence to established quality control and good manufacturing practices.
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ID · 23d81323-3cfc-4b77-93b8-46e606c038b3