FDA WARNING_LETTER - Koenen Dairy Inc - May 14, 2012

On May 11-14, 2012, an FDA investigation of Koenen Dairy Inc. in Hawarden, IA, confirmed a market dairy cow sold on January 30, 2012, for human food, contained 39.11 ppm of tetracycline in the kidney, exceeding the 12 ppm tolerance (21 CFR 556.500). This adulterates the food under Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act.

Additionally, USDA/FSIS identified another dairy cow from the operation on October 27, 2011, with 0.135 ppm of flunixin in the liver, exceeding the 0.125 ppm tolerance.

The investigation also revealed inadequate conditions, making it likely that medicated animals with harmful drug residues enter the food supply. Koenen Dairy Inc. lacks an adequate system to ensure appropriate drug withdrawal times. Specific deficiencies include failure to maintain treatment records, lack of an adequate drug inventory system, and no system to control drug administration. These conditions cause food from such animals to be adulterated under Section 402(a)(4) of the Act.

Koenen Dairy Inc. must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A