FDA WARNING_LETTER - Lussier Dairy, Inc. - December 05, 2014

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On January 26, 2015, the FDA issued a Warning Letter to Lussier Dairy following a December 3-5, 2014, inspection. The letter identified multiple violations of the Federal Food, Drug, and Cosmetic Act.

Two dairy cows sold for slaughter were found to be adulterated. One cow, sold June 23, 2014, had desfuroylceftiofur (ceftiofur marker) at 8.16 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)). Another cow, sold July 14, 2014, had penicillin at 0.239 ppm in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510). These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA also found insanitary conditions, specifically a failure to maintain complete treatment records, making food adulterated under section 402(a)(4). Furthermore, the new animal drugs Bactracillin G and Excede were adulterated under section 501(a)(5) due to extralabel use not in compliance with 2

Company: Lussier Dairy, Inc.
Inspection Date: December 5, 2014
Product Type: Drugs
Office: Florida District Office
Person: Susan M. Turcovski (Deputy Program Director)

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ID · 62da7dca-8ceb-480e-bddb-d4d54d9f029d

Violation Codes10

21 U.S.C. 342(a)(2)(C)(ii)21 U.S.C. 360b21 U.S.C. 342(a)(4)21 CFR 556.113(b)(3)(i)21 CFR 556.51021 U.S.C. 360b(a)(4)21 U.S.C. 360b(a)(5)21 CFR 53021 CFR 530.3(a)21 CFR 530.11(a)

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