FDA 483 - GCP Laboratories - May 13, 2022

GCP Laboratories in Gulfport, MS, an OTC drug manufacturer, received a Form 483 with seven observations during an inspection from May 9-13, 2022. The observations highlight significant deficiencies in equipment maintenance, microbial control procedures, process validation, batch record documentation, material storage, quality control unit authority, and warehouse conditions. These issues indicate potential risks to drug product quality and purity.