FDA WARNING_LETTER - Gro-Lan Farms - April 12, 2011

On October 17, 2011, the FDA issued a Warning Letter to Gro-Lan Farms following an investigation on April 12, 2011, at their dairy farm in Shippensburg, PA. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, two bob veal calves sold for slaughter were found to be adulterated. On October 28, 2010, a calf sold by Gro-Lan Farms contained Gentamicin in kidney tissue, for which FDA has no established tolerance in veal calves. Additionally, on December 9, 2010, another calf sold by Gro-Lan Farms contained 2.97 ppm of Flunixin in liver tissue, exceeding the FDA tolerance of 0.125 ppm. These findings render the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation found that animals were held under insanitary conditions, specifically due to a failure 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.

Gro-Lan Farms was instructed to take prompt action to correct these violations and establish procedures to prevent recurrence. While the FDA acknowledged ongoing changes to medical treatment records, they lacked sufficient information to evaluate their