# FDA WARNING_LETTER - Maple Lane Dairy, Inc. - September 26, 2013

Source: https://www.keypedia.com/records/warning_letter/maple-lane-dairy-inc/cacde2a3-3945-4566-8d0e-5972369130d1

> FDA WARNING_LETTER for Maple Lane Dairy, Inc. on September 26, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Maple Lane Dairy, Inc.
- Inspection Date: 2013-09-26
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On September 18, 23, and 26, 2013, the FDA inspected Maple Lane Dairy, Inc., identifying violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on December 6, 2012, was found to have desfuroylceftiofur at 0.68 ppm in kidney tissue, exceeding the 0.4 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed unsanitary conditions, including a failure to maintain complete treatment records, indicating that medicated animals with potentially harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the firm adulterated new animal drugs, specifically penicillin G procaine and flunixin meglumine, by using them extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a). This included administering penicillin G procaine to a cow without following label directions for dose, injection site amount, duration, and frequency, and administering flunixin meglumine to a calf without following label directions for dose and route. These extralabel uses caused the drugs to be unsafe under 21 U.S.C. §

## Related Officers

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

Company: https://www.keypedia.com/companies/maple-lane-dairy-inc/1318d56e-37cf-4063-b187-e02c135aeb46

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