FDA 483 - RX South DBA RX3 Compounding Pharmacy LLC - April 18, 2016

An FDA inspection of RX South DBA RX3 Compounding Pharmacy, LLC, a producer of sterile drug products, was conducted from April 11-18, 2016. The inspection revealed multiple significant deviations from regulatory standards for manufacturing sterile drugs.

Key deficiencies included inadequate aseptic processing controls, such as brown stains on HEPA filters and rusty support structures in clean areas. Cleaning and disinfection procedures were found lacking, with no sporicidal disinfectants used in critical ISO 5 and ISO 7 classified areas. A major concern was the absence of adequate validation for sterilization processes, including for glycerin injectable and the depyrogenation of glassware, and media fills that did not simulate challenging conditions.

Environmental monitoring was also cited as insufficient, with viable and non-viable particulate monitoring not performed daily, and personnel monitoring being infrequent. Additionally, pressure differential gauges were uncalibrated, and certain pressure differentials were undocumented. The firm also lacked a written program to assess drug product stability, failing to test sterility, endotoxin, and potency throughout product shelf lives. Lastly, improper protective apparel was observed, with a technician exposing skin during aseptic processing.

These observations highlight multiple failures to adhere to current Good Manufacturing Practices for sterile drug production. RX South DBA RX3 Compounding Pharmacy, LLC is expected to implement comprehensive corrective and preventive actions to ensure product quality and sterility, and to achieve full compliance with FDA regulations.