FDA 483 - Montana Compounding Pharmacy PC - September 22, 2021

An FDA inspection of Montana Compounding Pharmacy P.C. in Missoula, MT, revealed a repeat observation concerning the production of non-sterile drug products. The firm failed to provide adequate containment, segregation, and cleaning practices to prevent cross-contamination of highly potent and hazardous drugs. This deficiency poses a significant risk to product quality and patient safety.