FDA WARNING_LETTER - R and D Adams - February 11, 2015

The FDA conducted an inspection of Rand D Adams d/b/a/ David and Lisa Adams Dairy Farm in Randolph, NY, on January 21, 27, and February 11, 2015. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale a dairy cow for slaughter as food that was adulterated, specifically containing 0.195 ppm of flunixin residue in the liver, exceeding the established tolerance of 0.125 ppm (21 C.F.R. 556.286), rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Furthermore, the farm held animals under inadequate conditions, including a failure to maintain complete treatment records for medicated animals, making it likely that animals with harmful drug residues could enter the food supply, constituting adulteration under 21 U.S.C. 342(a)(4). The new animal drug, Flunixin Meglumine, was also found to be adulterated because it was used in an extralabel manner, not as directed by approved labeling. This extralabel use involved administering the drug without following the specified route and slaughter withdrawal time, and critically, without the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)), resulting in illegal residues (21 C.F.R. 530.11(d)). This rendered the drug unsafe and adulterated under 21 U.S.C. 360b(a) and 351(a)(5). The FDA requires prompt corrective actions and procedures to prevent recurrence. The firm's February 23, 2015, response was deemed inadequate for not detailing actual corrective steps. The farm must provide a written response within fifteen working days outlining all corrective actions taken or planned, with documentation, to avoid further regulatory action such as seizure or injunction.