FDA WARNING_LETTER - Hamlin Valley Farms, Inc. - December 28, 2007

An FDA inspection of Hamlin Valley Farms, Inc. in Strum, Wisconsin, on December 21 and 28, 2007, revealed multiple violations. A dairy cow (ear tag #4287) consigned for slaughter on September 13, 2007, was found to have 0.06 ppm ampicillin in kidney tissue, exceeding the 0.01 ppm tolerance (21 CFR § 556.40), rendering the food adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The farm lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate periods, failing to maintain reliable treatment records for withdrawal times. This caused the new animal drug ampicillin to become unsafe (section 512(a) of the Act) and adulterated (section 501(a)(5) of the Act). The extralabel use of ampicillin violated 21 CFR Part 530, specifically 21 CFR § 530.11(a) for not following the veterinarian's six-day withdrawal period without supervision, and 21 CFR § 530.11(d) for resulting in an illegal drug residue. Additionally, the firm provided a false