# FDA WARNING_LETTER - Schmidt, James - February 01, 2018

Source: https://www.keypedia.com/records/warning_letter/schmidt-james/22e5d53c-fce0-4e75-8b51-c7a399d1d896

> FDA WARNING_LETTER for Schmidt, James on February 01, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Schmidt, James
- Inspection Date: 2018-02-01
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: On January 10, 16, and February 1, 2018, the FDA inspected James L. Schmidt's facility in Cleveland, Wisconsin, revealing violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated cow for slaughter on October 3, 2017. USDA/FSIS analysis of tissue samples from this animal identified desfuroylceftiofur at 1.137 ppm in kidney tissue and flunixin at 0.293 ppm in liver tissue. These levels exceed the FDA's established tolerances of 0.4 ppm for desfuroylceftiofur (21 CFR 556.113(b)(3)(i)) and 0.125 ppm for flunixin (21 CFR 556.286(b)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the owner admitted to occasionally administering flunixin meglumine via intramuscular injection, an unapproved route, which constitutes an extralabel drug use violation under sections 512(a)(4) and (5) of the Act and 21 CFR Part 530. Treatment records were also unavailable for review, a recurring issue noted in a previous FDA inspection on April 25, 2

## Related Officers

- [Acting Assistant Commissioner](https://www.keypedia.com/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)

Company: https://www.keypedia.com/companies/schmidt-james/861676f2-4b4f-451d-9b39-96b0cf7a1c23

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d