# FDA WARNING_LETTER - Spring Water Farm, LLC - October 26, 2012

Source: https://www.keypedia.com/records/warning_letter/spring-water-farm-llc/cc28901d-5450-41a3-876d-032f1447ec0c

> FDA WARNING_LETTER for Spring Water Farm, LLC on October 26, 2012. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Spring Water Farm, LLC
- Inspection Date: 2012-10-26
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On October 24 and 26, 2012, the FDA inspected Spring Water Farm, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on August 16, 2012, was found to have desfuroylceftiofur in its kidney at 1.36 ppm, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The farm also held animals under unsanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the farm illegally used new animal drugs Excede (ceftiofur) and Tetrasol (tetracycline hydrochloride) extralabelly. Excede was administered without following approved labeling or veterinary directions, resulting in illegal residues (21 C.F.R. 530.11(d)). Tetrasol was administered without following conditions of use, route, dosage, or animal class, and not under veterinarian supervision (21 C.F.R. 53

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/spring-water-farm-llc/357f6362-c0f1-4101-a494-d9628ca54108

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