FDA WARNING_LETTER - Stoney Hill Farms - May 22, 2014

On September 30, 2014, the FDA issued a Warning Letter to Stoney Hill Farms, following an investigation on May 22, 2014, at their dairy farm in Saltsburg, Pennsylvania. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on October 31, 2013, Stoney Hill Farms sold a bob veal calf for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from the calf identified dihydrostreptomycin at 5.9 ppm in the kidney tissue, exceeding the FDA tolerance of 2.0 ppm for uncooked edible cattle tissues (21 C.F.R. 556.200). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found that animals were held under insanitary conditions, specifically due to a failure to maintain complete treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. This is deemed adulteration under section 402(a)(4) of the FD&C Act.

Stoney Hill Farms was instructed to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions was required within fifteen working days, with potential regulatory actions like seizure or injunction if not addressed.