# FDA WARNING_LETTER - Paskewitz, Barry J. - December 13, 2007

Source: https://www.keypedia.com/records/warning_letter/paskewitz-barry-j/d8fed5a1-aed4-479c-a5bf-72f43af5aa5b

> FDA WARNING_LETTER for Paskewitz, Barry J. on December 13, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Paskewitz, Barry J.
- Inspection Date: 2007-12-13
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: An FDA investigation, conducted by the Minnesota Department of Agriculture on December 13, 2007, at Barry J. Paskewitz's cattle operation in Redwood Falls, Minnesota, confirmed that an animal was offered for slaughter as food that was adulterated. Tissue samples from a cow revealed 0.21 ppm penicillin in kidney tissue, exceeding the 0.05 ppm tolerance established in 21 CFR § 556.510, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act. The investigation also found that animals were held under inadequate conditions, allowing medicated animals with potentially harmful drug residues to enter the food supply, which constitutes adulteration under section 402(a)(4) of the Act. A significant deficiency identified was the lack of a system to ensure animals sold for slaughter have not been medicated, or if so, to ensure appropriate withdrawal times to deplete drug residues from edible tissues. Mr. Paskewitz is required to take prompt action to correct these violations and establish procedures to prevent recurrence, including implementing a system to track animal source, medication, and withdrawal periods. A written response detailing corrective actions, including documentation, is due within 15 working days to avoid further regulatory action such as seizure or injunction.

## Related Officers

- [Director W.](https://www.keypedia.com/people/charles-becoat/d7cf567a-d89f-4e05-a3a6-67fed1ce4520)
- [Program Division Director](https://www.keypedia.com/people/elizabeth-a-waltrip/e11f7ba9-20f9-40f7-a44b-41629c6b53b0)

Company: https://www.keypedia.com/companies/paskewitz-barry-j/3a8d19b3-e74b-4992-97f7-87abe9aeae6a

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