FDA 483 - First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - September 12, 2022
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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.
- Inspection Date
- September 12, 2022
- Product Type
- Drugs
- Office
- Denver District Office
- Person
ID · 9d74a0eb-216d-433d-bc39-cf5b493882da