FDA WARNING_LETTER - Lym-R-Flo Farm - March 12, 2012

On March 6, 9, and 12, 2012, the FDA investigated Lym-R-Flo Farm, a dairy operation in Johnstown, New York. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of an adulterated animal for slaughter.

Specifically, on July 12, 2011, the farm sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on July 13, 2011, identified tulathromycin in kidney tissue, flunixin at 0.141 ppm in liver tissue, and penicillin at 0.11 ppm in kidney tissue. These drug residues exceeded established tolerances or were present in a species for which no acceptable level is permitted (tulathromycin and flunixin in veal calves), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that the farm held animals under insanitary conditions, specifically failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The FDA requires the farm to take prompt action to correct these violations and establish procedures to prevent recurrence. Failure