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

From June 5-14, 2019, the FDA inspected First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, a producer of sterile and non-sterile drug products in Mesa, AZ. The inspection, led by Bryan L Mcguckin, Investigator, identified twelve observations regarding deficiencies in their manufacturing processes and quality systems.

Key violations include inadequate validation of aseptic and sterilization processes, such as unvalidated sterilization equipment, lack of endotoxin challenge verification, and insufficient media fills and dynamic smoke studies (Observation 1). Aseptic processing areas were deficient in cleaning and disinfection, using non-sterile wipes and disinfectants without verified sporicidal activity (Observation 2). Environmental monitoring was insufficient, with only quarterly monitoring of ISO zones, pressure differentials, and personnel, and no alarm systems for air quality breaches (Observation 3). Airflow control in the ISO5 zone was compromised by a swaying curtain and exposed skin of the sterile drug tech (Observation 4).

The firm failed to investigate unexplained discrepancies, specifically viable air sample excursions in ISO7 and hazardous drug rooms (Observation 5). Personnel clothing was inappropriate for sterile production, with non-sterile attire and poor gowning practices observed (Observation 6). There was no written stability testing program for extended Beyond Use Dates (BUDs) of high-risk sterile products (Observation 7). Finished sterile drug products lacked sterility and pyrogen testing (Observation 8) and potency testing (Observation