# FDA WARNING_LETTER - John Malcore Livestock LLC - April 09, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/john-malcore-livestock-llc/ad29191f-a3d5-42b5-bb07-5166e4738c2b

> FDA WARNING_LETTER for John Malcore Livestock LLC on April 09, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: John Malcore Livestock LLC
- Inspection Date: 2012-04-09
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On February 28, March 17, and April 9, 2012, the FDA investigated John Malcore Livestock, LLC's cattle operation in Luxemburg, Wisconsin. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on December 27, 2011, a steer sold for slaughter by John Malcore Livestock, LLC, was found to have flunixin at 1.03 ppm in its liver, exceeding the tolerance of 0.125 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also failed to maintain complete treatment records, leading to conditions where medicated animals with potentially harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the firm illegally obtained and used by-prescription-only animal drugs, including (b)(4) (flunixin meglumine) Injectable Solution, without a valid veterinarian/client/patient relationship or licensed veterinarian's supervision. The extralabel use of (b)(4) (flunixin meglumine) Injectable Solution on a steer, not following the approved route of administration, resulted in an illegal drug residue, violating 21 CFR 530.11(a) and (

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/john-malcore-livestock-llc/72bcd5de-e729-4cc0-9046-61f8ba4f440d

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861