FDA 483 - Auro Pharmacies, Inc. - August 12, 2022

Auro Pharmacies, Inc. in La Habra, CA, a compounding pharmacy, was cited for two observations during an FDA inspection. The inspection revealed inadequate containment and cleaning practices for hazardous drug production, leading to potential cross-contamination. Additionally, non-microbial contamination, specifically white powder accumulation, was observed in production areas used for both hazardous and non-hazardous drug encapsulation.