# FDA WARNING_LETTER - Rupert Veterinary Clinic - May 29, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/rupert-veterinary-clinic/7e505393-c62d-4892-b776-49e8ee7852cb

> FDA WARNING_LETTER for Rupert Veterinary Clinic on May 29, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rupert Veterinary Clinic
- Inspection Date: 2015-05-29
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On May 29, 2015, the FDA inspected Rupert Veterinary Clinic, LLC, finding violations related to extralabel drug use. Dr. Robert Ceglowski, DVM, caused the new animal drug sulfadimethoxine (ANADA (b)(4)) to be unsafe and adulterated under sections 512(a)(1) and 501(a)(5) of the FD&C Act, respectively, by failing to comply with 21 CFR Part 530, Extralabel Drug Use in Animals.

Specifically, Dr. Ceglowski prescribed sulfadimethoxine to calves for pneumonia at (b)(4) without ensuring the drug's extralabel use would not result in violative drug residues. This violated 21 CFR 530.20(a)(2)(iv), as a bob veal calf from (b)(4) was later found to contain illegal residues after slaughter.

Furthermore, adding sulfadimethoxine to wasted milk for calves caused the animal feed to be unsafe and adulterated under sections 512(a)(2) and 501(a)(6) of the FD&C Act, respectively. This constituted extralabel use of a medicated feed, which is prohibited by 21 CFR 530.11(b).

The FDA deemed the clinic's June 14, 2015, response inadequate,

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/rupert-veterinary-clinic/34a0d6ed-f7fa-4066-b9f1-9810cd165308

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d