FDA WARNING_LETTER - BRS Analytical Services, LLC - March 26, 2025

The FDA issued a Warning Letter to BRS Analytical Services, LLC following an inspection from March 10 to 26, 2025, at their St. Louis drug manufacturing and testing facility. The letter cites significant violations of Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR parts 210 and 211, which led to their drug products being deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.Key issues include a fundamentally unsuitable ISO 5 cleanroom design, featuring physical gaps and inadequate pressure control, which posed an unacceptable risk to the sterility of their sterile over-the-counter drugs. Environmental monitoring was found deficient, lacking routine viable air monitoring and proper particle monitor placement, and data was not routinely reviewed before batch release. Facility maintenance issues, such as discoloration and unclean surfaces, were also observed.Furthermore, the company failed to establish and follow appropriate procedures to prevent microbiological contamination. Inspectors noted poor aseptic practices, including operators blocking unidirectional airflow and using nonsterile materials. The media fill program was inadequate, with insufficient unit incubation and shortened simulation durations compared to commercial operations. Sterilization assurance was lacking, as the validation process for direct product contact parts was insufficient, and sterilizing filters were not routinely integrity tested. An inadequate smoke study also failed to demonstrate proper unidirectional airflow. BRS Analytical Services, LLC must address these critical deficiencies to ensure the quality and sterility of their drug products.