# FDA WARNING_LETTER - Edwin Brasil Dairy - March 31, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/edwin-brasil-dairy/e889516e-e336-4b00-960f-bc9cae76aa42

> FDA WARNING_LETTER for Edwin Brasil Dairy on March 31, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Edwin Brasil Dairy
- Inspection Date: 2014-03-31
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: On June 12, 2014, the FDA issued a Warning Letter to Edwin Brasil Dairy following an investigation conducted on March 12, 17, 25, and 31, 2014. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A heifer sold for slaughter on October 31, 2013, was found to be adulterated. Tissue samples from this animal contained desfuroylceftiofur at 2.24 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113), and flunixin at 0.2 ppm in liver tissue, exceeding the 0.125 ppm tolerance (21 C.F.R. 556.286). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the FD&C Act.

Furthermore, the dairy adulterated new animal drugs, including flunixin meglumine, penicillin G procaine, oxytetracycline hydrochloride, and tylosin,

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## Related Officers

- [Kathleen M. Lewis](https://www.globalkeysolutions.net/people/kathleen-m-lewis/c7f66b1a-d346-48cc-ab84-9ea6c2805268)

Company: https://www.globalkeysolutions.net/companies/edwin-brasil-dairy/04c0cdba-cc07-4b14-86cc-20c338a1688e

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df