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

An FDA inspection of First Royal Care Co. LLC, dba Red Mountain Compounding in Mesa, AZ, revealed significant deficiencies in their sterile drug production. Observations included a lack of dynamic certification for ISO-5 classified areas, the presence of difficult-to-clean surfaces on critical equipment, and inadequate procedures for preventing cross-contamination during hazardous drug manufacturing. These issues raise concerns about the sterility and safety of their drug products.