FDA 483 - First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - September 12, 2022

An FDA inspection of First Royal Care Co. LLC, operating as Red Mountain Compounding, took place from August 29, 2022, to September 12, 2022. As a producer of sterile and non-sterile drugs, the firm received a Form FDA 483 detailing significant observations that indicate potential violations of the Federal Food, Drug, and Cosmetic Act.

The main issues identified during the inspection include the failure to certify ISO-5 classified areas under dynamic conditions, specifically lacking verification of uni-directional airflow in the laminar airflow workstation used for hazardous sterile drug products. Furthermore, surfaces of the ISO 5 classified equipment were noted to be difficult to clean, which could compromise sterility. A critical observation highlighted inadequate containment, segregation, and cleaning procedures for hazardous drugs, as the written cleaning protocol for non-dedicated equipment lacked a deactivation agent, risking cross-contamination between hazardous and non-hazardous sterile products.

Red Mountain Compounding is required to respond to these observations by implementing prompt corrective actions to ensure compliance with regulatory standards for sterile drug manufacturing. The company is expected to submit a detailed plan to the FDA addressing each noted deficiency.