FDA WARNING_LETTER - Hyland Acres Jerseys, Ltd. - October 16, 2014

The FDA conducted an inspection of Hyland Acres Jerseys Ltd. on September 22 and October 16, 2014, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale a bob veal calf for slaughter that was found to contain 20.99 ppm of neomycin in its kidney, significantly exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the firm was found to hold animals under inadequate conditions, including a failure to maintain complete treatment and drug inventory records, which makes it likely that medicated animals with harmful drug residues could enter the food supply, adulterating food under 21 U.S.C. § 342(a)(4). The new animal drug NeoMed 325 Soluble Powder (Neomycin Sulfate) was also found to be adulterated. The firm engaged in extralabel use of the drug by administering it to a class of animal not specified in its approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. § 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. § 530.11(d). These actions caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Hyland Acres Jerseys Ltd. must take prompt action to correct these violations and establish procedures to prevent recurrence within fifteen working days, providing written notification and documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.