FDA WARNING_LETTER - Auro Pharmacies, Inc. - November 05, 2015

On December 13, 2016, the FDA issued a Warning Letter to Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy, following an inspection from September 22 to November 5, 2015. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and exhibited serious deficiencies in sterile drug product manufacturing, posing patient risks.

Violations included exposing vials to sub-ISO 5 air, poor aseptic practices (e.g., operator placing gloved hands/elbows on ISO 5 hood), failure to use sporicidal agents for disinfection, storing sterilized items without established hold times, and improper fingertip monitoring.

These practices resulted in compounded drugs being unapproved new drugs (violating FDCA Sections 505(a) and 301(d)) and misbranded drugs (violating Sections 502(f)(1) and 301(a)) due to lack of adequate directions for use. Furthermore, sterile drug products were adulterated under Section 501(a)(2)(A) due to insanitary conditions. For drugs compounded without individual prescriptions, the firm was subject to CGMP regulations (21 CFR Parts 210 and 211), and significant CGMP violations were noted, leading to adulteration under Section 501(a)(2)(B). Specific CGMP failures included inadequate procedures for