auro pharmacies, inc., – FDA Warning Letter, Aug 2, 2018

An FDA inspection of Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy, from July 9 to August 2, 2018, revealed serious deficiencies in sterile drug product production and a failure to meet the conditions of section 503A of the FDCA. Specifically, the firm compounded drug products without valid prescriptions for individually-identified patients, rendering them ineligible for exemptions from CGMP, labeling, and FDA approval requirements. The inspection noted insanitary conditions, including vermin in production areas, visibly dirty ISO 5 equipment, inadequate media fills and smoke studies, improper aseptic manipulations, and persistent microbial contamination in the ISO 5 area, causing products to be adulterated under section 501(a)(2)(A). Additionally, significant CGMP violations, such as failure to conduct microbiological testing of components (21 CFR 211.84(d)(6)), establish stability testing programs (21 CFR 211.166(a)), and maintain facilities in good repair (21 CFR 211.58), led to products being adulterated under section 501(a)(2)(B). Consequently, these ineligible products were also deemed unapproved new drugs (sections 505(a), 301(d)) and misbranded due to lacking adequate directions for use (section 502(f)(1)). The firm voluntarily ceased sterile production and recalled sterile products. FDA recommends a comprehensive assessment by a third-party consultant if sterile operations resume, emphasizing full compliance with CGMP, new drug approval, and labeling requirements to prevent further legal action. A written response detailing corrective actions or intent not to resume sterile production is required within fifteen working days.