# FDA WARNING_LETTER - Van Ess Dairy LLC - May 10, 2012

Source: https://www.keypedia.com/records/warning_letter/van-ess-dairy-llc/42b6dab7-2281-4b3a-8eb0-5799d9db1dc6

> FDA WARNING_LETTER for Van Ess Dairy LLC on May 10, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Van Ess Dairy LLC
- Inspection Date: 2012-05-10
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On May 7-10, 2012, the FDA inspected VanEss Dairy LLC in Sanborn, IA. The inspection revealed a violation of the Federal Food, Drug, and Cosmetic Act concerning an adulterated animal sold for slaughter. Specifically, on or about December 1, 2011, VanEss Dairy LLC sold a cow (bangle tag # (b)(4)) for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on or about December 7, 2011, detected penicillin at 0.41 parts per million (PPM) in the kidney tissue. This level exceeds the FDA tolerance of 0.05 PPM for penicillin residues in cattle edible tissues, as codified in 21 C.F.R. § 556.510.

This presence of penicillin renders the food adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), because it contained an unsafe new animal drug under section 512 of the Act. VanEss Dairy LLC is responsible for ensuring compliance and preventing recurrence. The company must respond in writing within fifteen working days of receiving the letter, detailing corrective actions taken or planned, including documentation, to Danial S. Hutchison, Compliance Officer. Failure to comply may result in

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)
- [Consumer Safety Officer](https://www.keypedia.com/people/kevin-e-klommhaus/8a6295f0-c921-4432-8889-88b9fc37f5b6)

Company: https://www.keypedia.com/companies/van-ess-dairy-llc/13a3c2a3-1322-43fc-8edc-785212cbe049

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861