FDA WARNING_LETTER - AnazaoHealth Corporation - January 30, 2015

This FDA Warning Letter, dated December 9, 2015, addresses AnazaoHealth Corporation, an outsourcing facility registered under section 503B of the FDCA. An inspection from January 20-30, 2015, revealed serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations include: - **Insanitary Conditions:** Failure to use sterile wipes or disinfectants in ISO 7 and ISO 5 areas, leading to adulterated products (501(a)(2)(A) FDCA). - **CGMP Violations:** Adulterated drug products due to significant CGMP failures (501(a)(2)(B) FDCA), including: - Lack of written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)). - Failure to establish a cleaning/disinfecting system for aseptic conditions (211.42(c)(10)(v)). - Inadequate laboratory controls for specifications, sampling, and testing (21 CFR 211.160(b)). - Failure to investigate unexplained discrepancies or batch failures (21 CFR 211.192). - **503B Non-Compliance:** Failure to meet conditions for exemptions, resulting in unapproved new drugs and misbranded drugs: -