FDA WARNING_LETTER - Wilton Black - January 08, 2014

On February 28, 2014, the FDA issued Warning Letter CMS # 419585 to Wilton Black, owner, following an inspection on December 19, 2013, and January 8, 2014, at his Litchfield, ME operation. The inspection confirmed a bob veal calf, ear tag (b)(4), purchased, hauled, and sold by Black on February 5, 2013, was in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act).

On February 7, 2013, this calf was slaughtered in New York, and USDA/FSIS analysis of tissue samples identified flunixin in the kidney tissue. The FDA has not established a tolerance for flunixin residues in preruminating calves' edible tissues. The presence of this drug in edible tissues from this animal causes the food to be adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Black is required to take prompt action to correct the violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. As an animal dealer, Black shares responsibility for introducing adulterated animals into