FDA 483 - ChemPacific Corporation - February 15, 2024

An FDA inspection of ChemPacific Corporation in Baltimore, MD, an Active Pharmaceutical Ingredient manufacturer, revealed significant deficiencies in their quality control unit and manufacturing processes. The firm failed to thoroughly investigate out-of-specification and out-of-trend results for Norepinephrine Bitartrate, released product with microbiological contamination, and maintained unsanitary facility conditions. Additionally, issues were noted with incomplete batch production records, inadequate cleaning procedures, and a lack of qualified equipment for environmental control.