FDA WARNING_LETTER - AnazaoHealth Corporation - September 19, 2019

AnazaoHealth Corporation, an FDA-registered outsourcing facility, received a Warning Letter following a September 2019 inspection that revealed significant violations. The FDA investigator found that drug products produced by the facility failed to meet the conditions of section 503B of the FDCA, specifically regarding adverse event reporting. The facility's procedures for reporting adverse events were deemed inadequate, lacking definitions, timelines, and proper submission methods (SRP/ESG) as required by section 503B(b)(5) of the FDCA and 21 CFR 310.305. As a result, the compounded drug products are not eligible for exemptions under section 503B and are considered unapproved new drugs under sections 505(a) and 301(d) of the FDCA, as no FDA-approved applications are on file. Furthermore, these products are misbranded under section 502(f)(1) of the FDCA because their labeling fails to bear adequate directions for use. The FDA reviewed the facility's responses but was unable to fully evaluate the proposed corrective actions due to insufficient supporting documentation. The letter emphasizes the need for robust quality oversight, CGMP compliance (21 CFR parts 210 and 211), and proper adverse event reporting (21 CFR 211.198). Failure to correct these violations could lead to legal action, including seizure and injunction, and would subject the compounded drugs to full new drug approval, labeling, and Drug Supply Chain Security Act requirements. The facility must respond within 15 working days with specific corrective steps and documentation.