Elmer H. Zimmerman – FDA Warning Letter
On July 16, 2013, the FDA issued a Warning Letter to Elmer H. Zimmerman Dairy following a June 18, 2013 investigation. The letter identified multiple violations of the Federal Food, Drug, and Cosmetic Act.
A bob veal calf sold for slaughter on February 27, 2013, was found to have gentamicin in its kidney tissue, rendering it adulterated under 21 U.S.C. § 342(a)(2)(C)(ii) because FDA has not established a tolerance for gentamicin in cattle.
The dairy also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. § 342(a)(4). Specific deficiencies included failure to maintain treatment records and segregate treated dams from calves intended for veal.
Furthermore, the dairy adulterated a compounded drug containing GentaMax 100 (gentamicin sulfate) and FluMeglumine (flunixin meglumine) by not using it as directed by the veterinarian's prescription. This extralabel use, specifically administering the drug to dams and allowing calves to suckle without observing the prescribed withdrawal period, was not under veterinary supervision (21 C.F.R. 530.11(a)) and resulted in illegal residues (21 C.F.R.
- Company
- Elmer H. Zimmerman
- Product type
- Drugs
ID · 8ce3c6fe-b8d4-4c0a-bf9a-50ef4f5b1870
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