Akzo Nobel Chemicals, S.A. de C.V. – FDA Warning Letter, Jun 30, 2011

This FDA Warning Letter, dated November 16, 2011, was issued to Akzo Nobel Chemicals, S.A. de C.V. following a June 2011 inspection of their API manufacturing facility in Mexico. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their API adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to review and investigate production deviations:** Thirteen batches of (b)(4) API were contaminated with black particles, and hydraulic oil leaks were reported from manufacturing equipment. The firm failed to investigate the contaminant or root cause, and their response was inadequate regarding procedural changes, timelines, and disposition of affected API. 2. **Failure to prevent the use of quarantined API:** A contaminated lot was improperly released and shipped to the U.S. The firm's materials management system lacked appropriate identification for quarantined materials, and their quality unit failed to prevent the initial shipment. 3. **Inadequate maintenance procedure:** Ten maintenance requests for oil leaks between August 2010 and August 2011 indicated a deficient equipment maintenance program, with the firm continually authorizing the use of defective equipment without a prevention strategy.

The firm's July 11, 2011, response was deemed insufficient. Required corrective actions include revising deviation investigation procedures,