FDA WARNING_LETTER - J.D. Heiskell Holdings LLC - December 05, 2024

On June 12, 2025, the FDA issued a Warning Letter to J.D. Heiskell Holdings LLC following a December 2-5, 2024, inspection of their unlicensed feed mill in Twin Falls, Idaho. The inspection was prompted by a Reportable Food Registry (RFR) report filed by the firm on November 11, 2024, after receiving a consumer complaint on October 20, 2024, regarding multiple calf deaths linked to their Bliss Calf Starter medicated feed. A third-party lab confirmed excessive monensin in the feed, leading to a Class I recall on October 21, 2024.

The FDA identified significant violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), and CGMP for Medicated Feeds (21 CFR Part 225), rendering products adulterated and/or misbranded.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 507.33(c)(1)):** * Failure to control excess animal drug due to weighing error, as evidenced by a batch of Bliss Calf Starter containing 276 g/ton of monensin, far exceeding the intended concentration. The firm's prerequisite program was ineffective. * Lack