FDA 483 - MACSEN DRUGS - January 25, 2023

During an inspection conducted from January 17 to January 25, 2023, the U.S. Food and Drug Administration (FDA) identified significant deficiencies at Rowlett Prescription Shop. These observations, many of which were repeat issues from a previous inspection in 2018, indicate potential violations of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR Part 211.

Key violations centered on the production of sterile drug products. Inspectors noted that personnel engaged in sterile compounding did not wear appropriate protective apparel, such as gowns, shoe covers, hair bonnets, and face masks, risking product contamination. The firm also lacked a system for monitoring environmental conditions in aseptic processing areas, with no viable or non-viable air monitoring, surface sampling, or personnel glove/garb sampling ever conducted. Furthermore, cleaning and disinfection procedures for the cleanroom and laminar air flow hood were inadequate, utilizing non-sterile agents and lacking proper documentation.

Additional critical issues included the absence of procedures to prevent microbiological contamination, such as media fills, smoke studies, or current certification for the sterile hood. The company failed to perform essential sterility and endotoxin testing for sterile drug products and lacked supporting data for assigned Beyond-Use-Dates. Furthermore, finished drug products were not tested for identity and strength of active ingredients before release. Finally, Rowlett Prescription Shop lacked an independent quality control unit to oversee CGMP activities, with the owner performing all functions, including compounding and final product release, without proper oversight. The firm must address these serious, recurring deficiencies to ensure patient safety and regulatory compliance.