Montana Compounding Pharmacy PC – FDA 483, May 8, 2015

An FDA inspection of Montana Compounding Pharmacy and Wellness Center, conducted from April 28 to May 8, 2015, identified numerous critical deficiencies in the production of sterile drug products. The primary violations involved a pervasive lack of controls to prevent microbiological contamination and ensure product quality. The firm failed to conduct essential microbiological, analytical, sterility, or endotoxin testing on raw materials, including non-sterile, non-pharmaceutical grade components used in sterile injectables like "Trimix" and Hyaluronidase. Significant issues were observed in aseptic processing areas, including an unvalidated ISO 5 laminar air flow area, absence of media fill studies, and unqualified aseptic operators. The facility lacked proper environmental controls, with no HEPA leak tests, smoke studies for cleanrooms, or routine environmental monitoring. Furthermore, cleaning procedures were unwritten and ineffective, protective apparel was non-sterile and reused, and facility maintenance posed contamination risks, including dusty air ducts and pets in proximity to clean areas. The pharmacy also lacked a scientific stability program to establish Beyond Use Dates for sterile products, did not have written test procedures for sterility and pyrogens, maintained incomplete batch records, and had no procedures for managing complaints. To achieve compliance, the company must implement comprehensive material testing, validate aseptic processes and environmental controls, establish robust documentation, and ensure proper facility hygiene and equipment maintenance.