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

Source: https://www.globalkeysolutions.net/records/warning_letter/jd-heiskell-holdings-llc/d3b2f595-b360-4bf2-ac69-f78b07a4276d

> FDA WARNING_LETTER for J.D. Heiskell Holdings LLC on December 05, 2024. Product: Veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: J.D. Heiskell Holdings LLC
- Inspection Date: 2024-12-05
- Product Type: Veterinary
- Office Name: Center for Veterinary Medicine
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2024-12-04](https://www.globalkeysolutions.net/records/warning_letter/jd-heiskell-holdings-llc/4a822c7f-a471-4b82-8e77-4ac18265b22e)

## Related Officers

- [Isaac K. Carney](https://www.globalkeysolutions.net/people/isaac-k-carney/b5a04641-e0f1-4daa-914e-86f643ee080d)
- [Andrew J. Howard](https://www.globalkeysolutions.net/people/andrew-j-howard/d0469344-7828-4435-913d-a3463496b4e6)

Company: https://www.globalkeysolutions.net/companies/jd-heiskell-holdings-llc/290e17cd-5346-401d-907b-e37c1eee1a5e

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4