FDA 483 - CareFirst Specialty Pharmacy LLC - November 30, 2022

During an inspection on November 15, 2022, the FDA observed non-microbial contamination in the production area of the facility. Specifically, unidentified residue buildup was noted in both corners of the back wall of Bench 101. This bench is utilized for the production of drug products. The presence of this residue indicates a potential issue with the cleanliness and control of the manufacturing environment, which could impact the quality and safety of the drug products produced. This observation highlights a deficiency in maintaining a clean and controlled production environment as required by good manufacturing practices.