FDA 483 - Vita Pharmacy, LLC dba Talon Compounding Pharmacy - June 29, 2016

An FDA inspection conducted at Talon Compounding Pharmacy from June 21-29, 2016, identified significant deficiencies in its production of sterile drugs, indicating non-adherence to Good Manufacturing Practices. Key violations included deficiencies in cleanroom operations, such as an ISO 5 cleanroom failing certification yet being recorded as 'PASS,' and the continued use of non-compliant cleanrooms without investigation. Personnel practices were severely lacking, with observations of non-sterile gowning, improper aseptic techniques, and the use of expired disinfectants. The facility also failed to validate its sterilization processes, including lyophilization, and lacked adequate environmental and personnel monitoring programs. Furthermore, the company extended Beyond Use Dates (BUDs) for sterile products without supporting stability data or routine sterility and endotoxin testing. Investigations into distributed products found to be sub-potent or super-potent were not conducted, indicating a failure in the quality system. Many of these issues, particularly regarding sterilization process validation and routine testing for sterility/pyrogen-free products, were repeat observations from a previous 2015 inspection. Talon Compounding Pharmacy is required to implement comprehensive corrective and preventive actions to address these systemic failures, validate its processes, improve environmental controls, ensure proper aseptic techniques, and establish a robust quality system to ensure the safety and quality of its sterile drug products.