FDA 483 - King Pharmaceuticals LLC - February 18, 2025

The FDA inspection of King Pharmaceuticals LLC in Rochester, MI, revealed critical deficiencies across its sterile drug manufacturing operations. Issues included inadequate aseptic process controls, such as media fill design and environmental monitoring, and unscientific visual inspection methods for detecting particulates. Furthermore, the firm's quality control unit lacked proper authority for in-process material approval, and there was a systemic failure to thoroughly investigate and correct recurring foreign material contamination in sterile drug products.