FDA WARNING_LETTER - Tri-Med Laboratories Inc - September 25, 2009

This FDA Warning Letter, WL: #10-NWJ-07, dated February 23, 2010, was issued to Tri-Med Laboratories, Inc. following an inspection from September 9-25, 2009. The inspection identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's October 15, 2008 (believed to be 2009) response was deemed insufficient.

Key violations include: 1. **Failure to reject non-conforming materials (21 C.F.R. § 211.84(e))**: The Quality Control Unit (QCU) approved API Guaifenesin USP despite failing potency assays, invalidating original results without confirmed lab error. Purified water failing Coliform limits was also used for manufacturing without identifying a root cause for the failure. 2. **Inadequate investigation of discrepancies (21 C.F.R. § 211.192)**: The firm failed to thoroughly investigate aerobic plate count failures in purified water and humidity excursions in stability chambers. Root causes for these issues were not determined, and corrective actions were insufficient. This is a repeat violation from a 2008 Untitled Letter.