FDA WARNING_LETTER - Oberholtzer, Joseph N. - March 18, 2014

On February 11 and March 18, 2014, the FDA investigated Joseph N. Oberholtzer's dairy operation in New Holland, PA, identifying violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on August 5, 2013, a bob veal calf sold for slaughter was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 6, 2013, revealed dihydrostreptomycin at (b)(4) ppm in the kidney. While the FDA tolerance for dihydrostreptomycin in uncooked edible cattle tissues is 2.0 ppm (21 C.F.R. 556.200), this drug is not approved for use in bob veal calves, meaning no acceptable residue level exists. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the investigation found insanitary conditions, specifically a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. This renders food adulterated under section 402(a)(4) of the Act.

Mr. Oberholtzer is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may