FDA WARNING_LETTER - Glicerinas Industriales, S.A. de C.V. - May 12, 2023

On January 16, 2024, the FDA issued a Warning Letter to Glicerinas Industriales, S.A. de C.V. following an inspection from May 8-12, 2023, which revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). The facility's API are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test identity of incoming materials and qualify suppliers:** The firm failed to conduct adequate identity testing for high-risk components like glycerin USP, which are susceptible to diethylene glycol (DEG) or ethylene glycol (EG) contamination. The FDA cited previous warnings regarding this requirement. 2. **Failure to investigate deviations:** The firm did not adequately investigate observed particulate contamination (unidentified colored particulates, insects, hair, fibers) in numerous repackaged drug lots (glycerin, propylene glycol, and (b)(4)) over a three-month period. These contaminated lots were released without identifying a clear root cause or implementing timely corrective and preventive actions (CAPA). The firm acknowledged not investigating over 100 contaminated lots and failed to assess safety risks or customer notification.

The FDA recommends engaging a qualified CGMP consultant to perform a comprehensive six-system audit and assist in meeting CGMP requirements. The firm was placed on Import Alert