FDA WARNING_LETTER - Wright Place, LLC - December 15, 2009

The FDA conducted an investigation of The Wright Place, LLC's dairy operation in Clinton, Maine, on multiple dates in late 2009, identifying several violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale a bob veal calf for slaughter as food that was adulterated, as tissue samples revealed 10.99 ppm of neomycin residue in the kidney, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves when using the specific medicated milk replacer. This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the firm adulterated the new animal drug neomycin sulfate through extralabel use. Custom Calf White Plus NT Medicated Dairy Herd and Beef Calf Milk Replacer containing neomycin sulfate was fed to a bob veal calf without following approved labeling, violating 21 C.F.R. 530.11(b) for extralabel use in feed and 21 C.F.R. 530.11(c) for resulting in illegal drug residue. This non-conforming use caused the drug in the feed to be unsafe and adulterated (21 U.S.C. § 360b(a)(1), 21 U.S.C. § 351(a)(5)), and the animal feed itself to be unsafe and adulterated (21 U.S.C. § 360b(a)(2), 21 U.S.C. § 351(a)(6)). The FDA requires prompt corrective action and a written response within 15 working days, detailing steps taken to prevent recurrence, to avoid further regulatory action like seizure or injunction.