FDA 483 - Appco Pharma LLC - August 29, 2023

An FDA inspection of Appco Pharma LLC in Piscataway, NJ, a manufacturer of non-sterile drug products, revealed significant deficiencies across three observations. The firm failed to maintain adequate humidity control for drug product packaging and storage, did not follow established warehousing procedures for material identification and storage, and lacked proper training for Quality Control laboratory personnel, leading to repeated out-of-specification results.