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

Auro Pharmacies, Inc., a compounding pharmacy in La Habra, CA, underwent an FDA inspection from August 4 to August 12, 2022. The inspection led to the issuance of an FDA Form 483, citing two significant observations related to contamination control. Inspectors observed accumulations of white powder within hoods used for encapsulating hazardous drugs, including Progesterone, Estradiol, and Anastrozole. This indicated inadequate containment and cleaning protocols, presenting a clear risk of cross-contamination. Additionally, similar white powder accumulations were found in hoods designated for non-hazardous drug encapsulation, affecting products like Pregnenolone/DHEA, T3, T4/T3, and Naltrexone, indicating general non-microbial contamination in the production area. These findings highlight deficiencies in maintaining a controlled manufacturing environment and ensuring product quality. Pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, Auro Pharmacies, Inc. is expected to address these observations by discussing objections or submitting details of implemented or planned corrective actions to the FDA.