FDA 483 - First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - June 14, 2019

During an FDA inspection from June 5 to June 14, 2019, First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, a producer of sterile and non-sterile drug products, received 12 observations on Form FDA 483. The inspection revealed significant deviations from Current Good Manufacturing Practices (cGMP) intended to ensure product quality and patient safety. Key violations included a lack of adequate validation for aseptic and sterilization processes, such as equipment sterilization, depyrogenation, media fills, and smoke studies. The facility's cleaning and disinfection protocols for aseptic processing areas were found deficient, utilizing non-sterile materials and lacking verification for sporicidal activity. Environmental monitoring was insufficient, with infrequent checks for classified zones, pressure differentials, and personnel. Furthermore, issues with air quality control and improper personnel gowning and aseptic technique were noted. Regarding quality control, the firm lacked a written stability testing program to support extended Beyond-Use Dates for high-risk products. Critical finished product testing for sterility, pyrogens, potency, and objectionable microorganisms for non-sterile products was not conducted. Procedural deficiencies included a failure to investigate environmental monitoring excursions, inadequate cleaning and maintenance standard operating procedures that did not reflect actual practices, and inaccurate batch production records. The company is expected to provide a comprehensive response outlining its corrective and preventive actions to address these serious observations, ensuring compliance with regulatory standards for drug manufacturing.