David Homan – FDA Warning Letter, May 20, 2013
On May 15, 17, and 20, 2013, the FDA inspected United Parcel Service's dairy operation in Fort Recovery, Ohio. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.
Specifically, on April 4, 2013, a dairy cow sold for slaughter was found to have 0.807 ppm of sulfamethazine in its liver tissue, which is an unsafe new animal drug residue. This violates section 402(a)(2)(C)(ii) of the FD&C Act, rendering the food adulterated.
Additionally, the operation was found to hold animals under insanitary conditions, specifically failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This violates section 402(a)(4) of the FD&C Act, deeming the food adulterated.
The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines must be submitted to the FDA within fifteen working days of receiving the letter.
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