FDA 483 - First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - August 11, 2021

During an inspection from July 14 to August 11, 2021, the FDA identified significant manufacturing deficiencies at First Royal Care Co. LLC, operating as Red Mountain Compounding. The firm, a producer of sterile and non-sterile drugs, received a Form 483 detailing numerous observations related to its compliance with quality standards. Key violations included the use of non-pharmaceutical grade raw materials in both sterile and non-sterile products, posing a direct risk to patient safety. The company failed to perform essential sterility and pyrogen testing on finished sterile drug products, and its sterilization processes lacked proper validation to ensure efficacy against microorganisms. Additionally, there were critical shortcomings in maintaining aseptic conditions, such as inadequate routine environmental and personnel monitoring, and the use of expired, non-sterile protective apparel during sterile production. The firm also lacked a robust stability program to support assigned beyond-use-dates and did not routinely conduct potency testing on its finished products, raising concerns about product quality and strength. Damaged equipment and insufficient cleaning practices further highlighted control deficiencies. These observations indicate a departure from fundamental manufacturing requirements designed to ensure the safety, quality, and integrity of compounded drugs. Red Mountain Compounding is expected to address these findings comprehensively and submit a detailed plan of corrective actions to the FDA.