FDA WARNING_LETTER - Paul Pushlar - April 23, 2014

The FDA conducted an inspection of Paul Pushlar's dairy operation in Cazenovia, New York, on April 10, 11, and 23, 2014, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that an animal offered for slaughter as food was adulterated. Specifically, a bob veal calf sold on June 13, 2013, contained 70.6 ppm of dihydrostreptomycin in its kidney tissue, far exceeding the 2.0 ppm tolerance for cattle and not approved for bob veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the firm was found to hold animals under insanitary conditions, such as failing to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The new animal drug (b)(4) was also found to be adulterated. The firm engaged in extralabel use of this drug, administering 20 cc into one dosage site, contrary to its approved labeling. This extralabel use was not supervised by a licensed veterinarian, violating 21 C.F.R. 530.11(a), and caused the drug to be unsafe and adulterated under 21 U.S.C. § 351(a)(5). The FDA requires prompt corrective actions and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence, warning that failure to comply may lead to regulatory actions like seizure or injunction.