# FDA WARNING_LETTER - J.C. Maurer & Sons - May 08, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/jc-maurer-sons/ac45036b-5415-429e-bd1b-5bbf9ca1d1cf

> FDA WARNING_LETTER for J.C. Maurer & Sons on May 08, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: J.C. Maurer & Sons
- Inspection Date: 2012-05-08
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: The FDA conducted an investigation of J.C. Maurer & Sons, a contract heifer raising operation in Elkhart Lake, Wisconsin, on April 10 and May 8, 2012. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act concerning adulterated food. Specifically, the firm sold a dairy heifer for slaughter on December 30, 2011, which was found to contain unsafe levels of tilmicosin residues. Liver tissue contained 1.802 ppm and muscle tissue 1.294 ppm, exceeding FDA tolerances of 1.2 ppm and 0.1 ppm, respectively, as codified in 21 CFR 556.735(b)(1). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. Deficiencies included failure to maintain complete treatment records and failure to ensure proper drug withdrawal times were observed. These conditions cause food to be adulterated under section 402(a)(4) of the Act. J.C. Maurer & Sons is responsible for ensuring overall compliance. The FDA requires prompt corrective action and establishment of preventative procedures. A written response detailing corrective steps, timelines, and supporting documentation is due within 15 working days to avoid potential regulatory actions like seizure or injunction.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/jc-maurer-sons/21d9cd05-a908-4217-8061-b49cc98bc29d

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