FDA WARNING_LETTER - Quesnel Livestock - November 04, 2009

An FDA inspection of Quesnel Livestock in Middlebury, VT, conducted in September, October, and November 2009, confirmed that a dairy cow sold for human food slaughter on April 7, 2009, contained illegal residues of Penicillin (0.60 ppm, tolerance 0.05 ppm) and Flunixin (0.3355 ppm, tolerance 0.125 ppm) in its tissues. This renders the food adulterated under Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act), with drug tolerances codified in 21 CFR Part 556. The letter also noted a history of illegal residues in other livestock sold by the firm since 2000. The firm was cited for employing poor husbandry practices by failing to prevent the marketing of animals with illegal residues. Specific violations include failing to implement and maintain a system to identify purchased animals for traceability to their source and failing to determine the medication status of animals from their source. The introduction of adulterated food into interstate commerce is prohibited by Section 301(a) of the Act. Quesnel Livestock must promptly correct these violations and establish procedures to prevent recurrence, such as implementing a system to withhold medicated animals from slaughter for appropriate withdrawal periods or clearly identifying them. A written response detailing corrective actions is required within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.