FDA WARNING_LETTER - Ridley Block Operations Inc - January 25, 2017

The FDA issued a Warning Letter to Ridley Block Operations following a December 2016 - January 2017 inspection, prompted by a Reportable Food Registry report of nine cattle deaths from urea toxicity. The investigation confirmed the firm's animal feed, lot (b)(4), contained excessive non-protein nitrogen (NPN) (30.5-31.1% vs. 16% labeled maximum), rendering it adulterated under 21 U.S.C. 342(a)(1) and misbranded under 21 U.S.C. 343. State regulatory programs also identified numerous other misbranded lots.

The firm's operations were found to violate Current Good Manufacturing Practice (CGMP) requirements for animal food (21 CFR Part 507, Subpart B). Specific deficiencies included failure to ensure adequate precautions in plant operations (21 CFR 507.25(a)(5)), failure to reject or treat adulterated animal food (products with yield variances were distributed) (21 CFR 507.25(a)(7)), failure to examine raw materials for suitability (leading to manual adjustments) (21 CFR 507.25(b)(1)), and failure to conduct manufacturing steps to protect against contamination (inconsistent mixing, batch-to-batch adjustments) (21 CFR 507.25(c)(4)).

While the firm suspended large composite runs and plans a controlled batching system, their response lacked detailed corrective actions and timelines for ongoing small volume custom runs. Ridley Block Operations must promptly correct all violations and establish preventative procedures. A written response detailing corrective actions, timelines, and documentation is required within fifteen working days to avoid potential regulatory actions like seizure or injunction.