# FDA WARNING_LETTER - Jack Dei Dairy - September 14, 2012

Source: https://www.keypedia.com/records/warning_letter/jack-dei-dairy/1aa6cf6b-8185-4fec-a7e0-ad5aac57679b

> FDA WARNING_LETTER for Jack Dei Dairy on September 14, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jack Dei Dairy
- Inspection Date: 2012-09-14
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On December 11, 2012, the FDA issued a Warning Letter to Jack Dei Dairy following an investigation conducted on September 11, 12, and 14, 2012. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a bob veal calf sold for slaughter on April 22, 2012, was found to have flunixin at 1.36 ppm in liver tissue, exceeding the 0.125 ppm tolerance for cattle and having no established tolerance for calves, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The dairy also failed to maintain complete treatment records, leading to insanitary conditions where medicated animals with harmful drug residues could enter the food supply, adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the dairy adulterated new animal drugs, including Flunixin Meglumine, Penicillin G Procaine Injectable Suspension, Sulfadimethoxine Bolus, and Neomycin/Oxytetracycline Type C-Medicated Feed, through extralabel use. Flunixin was administered without observing the animal class, without licensed veterinarian supervision, and resulted in illegal residues (21 C.F.R. 530.11(

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