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Talk to a SpecialistTalk to a SpecialistJ.D. Heiskell Holdings LLC, an unlicensed feed mill in Twin Falls, Idaho, manufactured Bliss Calf Starter medicated feed that contained excessive monensin, resulting in multiple calf deaths and triggering a Class I recall in October 2024. The FDA inspection (December 2-5, 2024) identified significant violations of Current Good Manufacturing Practice and Hazard Analysis requirements under 21 CFR Part 507, finding that products were prepared under insanitary conditions that may have rendered them injurious to health. The company failed to comply with preventive controls provisions and manufactured medicated feed containing a super-potent concentration of monensin that did not conform to the drug approval requirements for the new animal drug.