FDA WARNING_LETTER - Triangle Compounding - January 16, 2015

The FDA issued Warning Letter 16-ATL-02 to Triangle Compounding Pharmacy, an outsourcing facility, following inspections from September 8-22, 2014, and January 12-16, 2015. These inspections, the first to evaluate the facility under Section 503B of the FDCA, identified significant violations.

The facility failed to meet conditions for exemptions under Section 503B, resulting in compounded drugs being adulterated and misbranded. Violations included: - **Failure to submit required drug product reports** upon initial registration and incomplete subsequent reports, violating Section 503B(b)(2). - **Compounding drugs on the withdrawn/unsafe list** (e.g., chlorhexidine gluconate), violating Section 503B(a)(4). - **Significant Current Good Manufacturing Practice (CGMP) violations** under Section 501(a)(2)(B), including: - Failure to thoroughly investigate discrepancies or batch failures (21 CFR 211.192). - Inadequate written procedures for in-process controls and tests (21 CFR 211.110(a)). - Failure to ensure adequate container closure systems (21 CFR 211.94(b)). - Failure to establish an adequate cleaning and disinfecting system for aseptic conditions