# FDA WARNING_LETTER - Sunny Boys Dairy - November 05, 2014

Source: https://www.keypedia.com/records/warning_letter/sunny-boys-dairy/49e6cc5e-8982-440a-a3d5-1ac77f05e874

> FDA WARNING_LETTER for Sunny Boys Dairy on November 05, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sunny Boys Dairy
- Inspection Date: 2014-11-05
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: On November 3-5, 2014, the FDA inspected Sunny Boys Dairy in Delta, Utah, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated the new animal drug (b)(4) (sterile Penicillin G Procaine, injectable suspension, (b)(4)) by using it extralabelly. Specifically, the drug was administered to a culled dairy cow, back tag (b)(4), without following the recommended dose and route of administration, and for treating Mastitis, a condition not identified in the approved product labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and rendering the drug unsafe under section 512(a) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)]. The FDA requires prompt corrective action to prevent recurrence, with a written response due within fifteen working days detailing steps taken or planned. Failure to comply may result in regulatory actions like seizure or injunction.

## Related Officers

- [District Director](https://www.keypedia.com/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.keypedia.com/companies/sunny-boys-dairy/edb31f30-7da4-4af1-bc56-2826b5982dbb

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