FDA WARNING_LETTER - Syfrett Feed Co. - January 09, 2014

The FDA issued a Warning Letter to Syfrett Feed Company, Inc. following a joint inspection in January 2014, prompted by the firm's Medicated Feed License application. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for unlicensed medicated feed manufacturers (21 CFR Part 225). Violations included failure to establish adequate procedures for identification and inventory control of medicated articles (21 CFR § 225.142), and failure to maintain facilities to minimize vermin and pest infestation (21 CFR § 225.120).

Furthermore, the firm was found using unapproved drug combinations in cattle and poultry feeds, specifically chlortetracycline and fenbendazole, and chlortetracycline, amprolium, and salinomycin, rendering these feeds unsafe and adulterated. Several medicated feeds were also misbranded because their labeling lacked the established name of the active drug ingredient and adequate directions for use, including indications, dosage, feeding limitations, and withdrawal periods (21 U.S.C. § 352(e)(1)(A)(ii) and § 352(f)(1)). Additionally, the firm failed to ensure all medicated feed deliveries were adequately labeled for consignee use (21 CFR § 225.180), with examples of incorrect drug concentrations on labels.

The company's response to the FDA 483 was deemed inadequate, lacking sufficient documentation for corrective actions and failing to address the unapproved drug combinations. Syfrett Feed Company must promptly investigate, correct all violations, and prevent recurrence. Failure to comply within 15 business days could lead to regulatory actions like seizure or injunction.