FDA WARNING_LETTER - Paul K Katzmaier

On November 29, 2012, the FDA inspected Paul K. Katzmaier's dairy operation in Montoursville, PA, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated bob veal calf for slaughter. Tissue analysis by USDA/FSIS revealed neomycin at 20.38 ppm in the kidney, significantly exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for bob veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the operation held animals under insanitary conditions, including inadequate treatment records and failure to segregate treated animals, increasing the likelihood of drug residues entering the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). The FDA also found that new animal drugs, neomycin and oxytetracycline, were adulterated (21 U.S.C. § 351(a)(5)) due to extralabel use not conforming to approved labeling. This included administering drugs in or on feed (21 C.F.R. § 530.11(b)) and resulting in illegal drug residues (21 C.F.R. § 530.11(c)). Additionally, medicated animal feed was adulterated (21 U.S.C. § 351(a)(6)) because it was not used according to its approved labeling, making it unsafe. Mr. Katzmaier is required to take prompt corrective action and establish preventative procedures. A written response detailing these steps, including documentation and a timeline for completion, must be submitted within fifteen working days to avoid potential regulatory actions like seizure or injunction.