# FDA WARNING_LETTER - Double Tree Dairy Farm, LLC - September 23, 2016

Source: https://www.keypedia.com/records/warning_letter/double-tree-dairy-farm-llc/d6f479b1-f106-42b8-889f-ada621deb994

> FDA WARNING_LETTER for Double Tree Dairy Farm, LLC on September 23, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Double Tree Dairy Farm, LLC
- Inspection Date: 2016-09-23
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: On September 21 and 23, 2016, the FDA investigated Double Tree Dairy Farm, LLC, finding violations of the FD&C Act. A dairy cow sold for slaughter on April 6, 2016, was found to have 5.25 ppm of desfuroylceftiofur in kidney tissue, exceeding the 0.4 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically inadequate record-keeping for medicated animals. Treatment records lacked dosage, route of administration, meat/milk withdrawal times, and administrator's identity, making it likely that animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug (b)(4) (ceftiofur) was adulterated because it was used extralabelly without veterinary supervision and resulted in an illegal drug residue. The farm admitted to selling a cow three days before its 13-day withdrawal period for (b)(4) was met, violating 21 CFR 530.11(a) and (d), and rendering the drug unsafe and adulterated under 21 U.S.C. § 360b

## Related Officers

- [District Director](https://www.keypedia.com/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)
- [Anna Gallegos](https://www.keypedia.com/people/anna-gallegos/a69112da-9614-4c2e-a8b8-4c39699669e0)
- [LuAnn Adams](https://www.keypedia.com/people/luann-adams/d9106474-8c7b-44b1-9a82-81302fac4f8d)

Company: https://www.keypedia.com/companies/double-tree-dairy-farm-llc/de9235b7-ead5-4587-90dd-5b5c28375972

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