# FDA WARNING_LETTER - Watson Dairy - March 20, 2013

Source: https://www.keypedia.com/records/warning_letter/watson-dairy/67452234-a4fc-4ed4-8ede-0fb55484be6e

> FDA WARNING_LETTER for Watson Dairy on March 20, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Watson Dairy
- Inspection Date: 2013-03-20
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: On March 13 and 19-20, 2013, the FDA investigated Watson Dairy in Sweetwater, Tennessee, and found violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on December 5, 2012, was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 6, 2012, revealed 0.315 ppm of penicillin in kidney tissue and 0.442 ppm of flunixin in liver tissue. These levels exceed the FDA tolerances of 0.05 ppm for penicillin and 0.125 ppm for flunixin in cattle tissues, rendering the food adulterated under Section 402(a)(2)(C)(ii) of the Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under Section 402(a)(4). Specifically, the dairy failed to maintain treatment records.

Furthermore, the new animal drugs Norocillin (penicillin G procaine) and Flunixin Meglumine were adulterated under Section 501(a)(5) because they were used extralabelly without the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). Norocillin

## Related Officers

- [Acting Program Director](https://www.keypedia.com/people/kimberly-l-mcmillan/ef529c1c-a23b-4fb8-89bc-7ca69dfa8d7b)

Company: https://www.keypedia.com/companies/watson-dairy/755533a2-abb1-4c96-a26c-8b204f3bdcf2

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea