FDA WARNING_LETTER - Dennis Loppnow - March 10, 2014

The FDA issued a Warning Letter to Dennis J. Loppnow and Patti K. Loppnow following inspections on February 13 and March 10, 2014, of their veal operation in Oconomowoc, Wisconsin. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. A significant finding was the sale of an adulterated veal calf containing 10.92 ppm of neomycin in kidney tissue, exceeding the 7.2 ppm tolerance and stemming from an unapproved drug use in veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the firm held animals under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. § 342(a)(4). This included a failure to maintain complete treatment records and an inadequate system to ensure drug withdrawal times. The company also adulterated new animal drugs (neomycin sulfate, chlortetracycline hydrochloride) and a human drug (Sulfamethoxazole and Trimethoprim Tablets) through improper extralabel use. Specific extralabel violations included lack of licensed veterinarian supervision (21 CFR 530.11(a)), administration in or on feed (21 CFR 530.11(b)), and resulting in illegal drug residues (21 CFR 530.11(c)). Additionally, animal feed was adulterated by adding these drugs to milk replacer, making it unsafe (21 U.S.C. § 351(a)(6)). The FDA requires prompt corrective actions, including documentation of steps taken to prevent recurrence, within 15 working days, noting the firm's previous response was inadequate due to lack of evidence. Failure to comply may result in regulatory action.