FDA WARNING_LETTER - Tri State Agri Services, Llc - March 01, 2012

An FDA inspection of Tri State Agri Services, LLC, a licensed medicated feed mill, from February 15 to March 1, 2012, revealed significant Current Good Manufacturing Practice (CGMP) deviations (21 CFR Part 225) and issues with their medicated feed, Stocker Mineral C-3500 B-2100. CGMP violations included failure to perform required assays, inadequate investigation and corrective actions for out-of-limits assay results, insufficient procedures to prevent cross-contamination, failure to follow master record formulas, lack of documented corrective actions for production record discrepancies, incomplete master record files (not dated/signed or retained), and incomplete complaint records. Many of these were recurring observations from prior inspections. Additionally, the firm manufactured and distributed Stocker Mineral C-3500 B-2100 with an unapproved concentration of lasalocid, exceeding approved levels (21 CFR 558.311(e)(1)(xxviii)). This rendered the medicated feed unsafe and adulterated (FD&C Act Sections 512(a)(2)(A)(i), 501(a)(6)) and the drug lasalocid unsafe and adulterated (FD&C Act Sections 512(a)(1)(A), 501(a)(5)). The product was also misbranded (FD&C Act Section 502(f)) due to inadequate directions for use, leading to sub-potent chlortetracycline levels. The firm's response lacked supporting documentation for claimed corrective actions. Tri State Agri Services must promptly correct all violations and establish preventive procedures. A written response detailing corrective steps and timelines, with documentation, is required within 15 working days. Failure to comply may result in sanctions, including license withdrawal, seizure, or injunction.