FDA WARNING_LETTER - Fieser Dairy, Inc. - November 17, 2011

On November 16 and 17, 2011, the FDA inspected Fieser Dairy, Inc., identifying violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale adulterated animals for slaughter. Specifically, two dairy cows sold on August 15, 2011, and slaughtered on August 16, 2011, contained sulfamethazine residues in liver and muscle tissue (0.134 ppm and 0.063 ppm in one, 0.245 ppm and 0.076 ppm in the other), for which FDA has no established tolerance in lactating dairy cattle. This violates 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, violating 21 U.S.C. § 342(a)(4).

Furthermore, the firm adulterated new animal drugs, including chlortetracycline plus sulfamethazine and decoquinate medicated feeds, by using them extra-label without veterinary oversight and not as directed by approved labeling. This included administering an unapproved combination of drugs in animal feeds, not following specified duration of treatment, withdrawal periods, or animal class. Specific violations include extralabel use