# FDA WARNING_LETTER - Antonio Resendes - October 28, 2011

Source: https://www.keypedia.com/records/warning_letter/antonio-resendes/0327d695-cf54-443c-9be6-9f090a694b78

> FDA WARNING_LETTER for Antonio Resendes on October 28, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Antonio Resendes
- Inspection Date: 2011-10-28
- Product Type: Drugs
- Office Name: New England District Office
- Summary: On October 14, 18, and 28, 2011, the FDA investigated Antonio Resendes' dairy operation in Bridgeport, Vermont. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on June 16, 2011, Resendes sold a calf for slaughter that was found to have sulfamethoxazole at 0.055 ppm in its liver tissue by USDA/FSIS. Since FDA has no tolerance for sulfamethoxazole in veal calves, this rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including failure to maintain drug treatment and inventory records, and lack of a system to discard expired drugs. These conditions mean medicated animals with harmful drug residues could enter the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Resendes adulterated human drugs Sulfamethoxazole and Trimethoprim by using them extralabelly without a licensed veterinarian's supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This caused the drug to be unsafe under section

## Related Officers

- [District Director](https://www.keypedia.com/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)

Company: https://www.keypedia.com/companies/antonio-resendes/8e64c793-b8a0-43b2-a105-8f652eaab63c

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144