# FDA WARNING_LETTER - Rocky Top Dairy - January 17, 2008

Source: https://www.keypedia.com/records/warning_letter/rocky-top-dairy/e2ef123e-078b-4ccf-ab35-52460c19a4aa

> FDA WARNING_LETTER for Rocky Top Dairy on January 17, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rocky Top Dairy
- Inspection Date: 2008-01-17
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: On January 9-17, 2008, an FDA inspection of Rocky Top Dairy in Lovington, New Mexico, revealed that the dairy offered adulterated animals for slaughter and caused new animal drugs to become unsafe and adulterated.

Specifically, a Holstein cow sold on September 18, 2007, for slaughter contained 1.19 ppm Penicillin in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The dairy lacked an adequate system to ensure proper drug withdrawal times, failing to maintain complete treatment records, which adulterated food under 21 U.S.C. § 342(a)(4).

Furthermore, the dairy's extralabel use of [redacted] Injectable Suspension U.S.P. was non-compliant with 21 C.F.R. Part 530. The dairy administered six times the recommended dose without licensed veterinarian supervision, violating 21 C.F.R. § 530.11(a), and this extralabel use resulted in illegal drug residues, violating 21 C.F.R. § 530.11(d). This rendered the drug unsafe under 21 U.S.C. § 360b(a

## Related Officers

- [H.](https://www.keypedia.com/people/thomas-warwick/62a2152a-d2c5-4362-bd12-f90807ff0b26)

Company: https://www.keypedia.com/companies/rocky-top-dairy/e9401174-3c65-4efc-bc09-45ac5abb203a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face