FDA 483 - Unipack LLC - October 16, 2020
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US Pharmaceuticals Inc. in Belleville, NJ, an OTC drug manufacturer, was cited for significant deficiencies in its quality control unit and production record management. The inspection revealed issues including duplicated batch manufacturing data, lack of oversight for record destruction and deleted lab results, and distribution of drug products without proper quality control release. These findings indicate serious concerns regarding data integrity and adherence to established procedures.
ID · f3b8ff8d-b003-4dfd-859f-5dd7b9f3feff