483
Pharmaceutics International IncFDA 483 - Pharmaceutics International Inc - November 14, 2022
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