# FDA WARNING_LETTER - James W. Michalek - September 26, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/james-w-michalek/79d104c7-d4a3-49cd-aa5a-5e1058804f10

> FDA WARNING_LETTER for James W. Michalek on September 26, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: James W. Michalek
- Inspection Date: 2013-09-26
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On September 18-26, 2013, the FDA inspected Michalek's dairy operation in Attica, NY, and found violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on March 28, 2013, was found to have unsafe levels of tulathromycin and flunixin meglumine in its kidney tissue, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the new animal drugs (b)(4) (Tulathromycin) Injection and (b)(4) (Flunixin Meglumine) Injection were adulterated because they were used in an extralabel manner without following approved labeling for animal class and withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(c). This rendered the drugs unsafe under 21 U.S.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/james-w-michalek/37a1de87-195c-4070-809d-b90624ce78f5

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