FDA WARNING_LETTER - Sugarcreek Livestock Auction, Inc. - June 24, 2019

The FDA conducted an inspection of the Livestock Auction in Sugarcreek, Ohio, on April 29-30 and June 24, 2019, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm was found to hold animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply, rendering food adulterated under Section 402(a)(4) of the FD&C Act. Specific deficiencies included a failure to maintain treatment records, inability to provide documentation notifying buyers of medicated animals, and a lack of an adequate system to identify and segregate medicated animals. Furthermore, the inspection documented unsanitary practices, such as storing dirty, used syringes in bottles of ceftiofur animal drugs. The FDA also noted the apparent extra-label use of medications without a prescription, which may violate Sections 512(a)(4) and (5) of the FD&C Act and 21 CFR Part 530, requiring a valid veterinarian/client/patient relationship. The firm is required to take prompt corrective action, establish preventative procedures, and submit a written response within 15 working days detailing these steps and providing documentation. Failure to comply may lead to regulatory actions like seizure or injunction. The firm had not responded to the Form FDA 483 issued prior to this letter.