FDA WARNING_LETTER - Legacy Dairy Farms LP - June 20, 2008

The FDA conducted an inspection of Legacy Dairy Farms LP on June 19-20, 2008, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of adulterated animals for slaughter, specifically two dairy cows found with illegal drug residues. One cow sold on March 7, 2008, contained oxytetracycline at 14.30 ppm (tolerance 12 ppm) and flunixin at 0.184 ppm (tolerance 0.125 ppm) in edible tissues. Another cow sold on March 14, 2008, had flunixin at 3.427 ppm (tolerance 0.125 ppm). These residues render the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the firm was cited for holding animals under inadequate conditions, making it likely that medicated animals with harmful residues would enter the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). A contributing factor was the failure to maintain complete treatment records. The new animal drug oxytetracycline was also found to be adulterated because it was used in an extralabel manner, not as directed by its approved labeling. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residues (21 C.F.R. 530.11(d)), causing the drug to be unsafe and adulterated under 21 U.S.C. § 351(a)(5). Legacy Dairy Farms must take prompt corrective action and respond within 15 working days, detailing steps taken to prevent recurrence, or face potential regulatory actions like seizure or injunction.