United Producers, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to United Producers, Inc. following an April 3, 2015, inspection of their St. Louis, MI, auction facility. The letter details violations of the Federal Food, Drug, and Cosmetic Act related to offering adulterated animals for slaughter. Specifically, an investigation revealed that a Holstein bull calf consigned for sale in March 2014, and later sent for slaughter by United Producers, contained unsafe levels of florfenicol and flunixin residues in its liver and muscle tissues, exceeding established FDA tolerances (21 C.F.R. §§ 556.283(b) and 556.286(b)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act. Furthermore, the FDA found that United Producers, Inc. holds animals under inadequate conditions, specifically lacking a system to ensure that medicated animals are withheld from slaughter for appropriate withdrawal periods to deplete potentially hazardous drug residues. This practice renders food adulterated under section 402(a)(4) of the Act. The FDA requires prompt corrective action, including implementing a system to identify medicated animals and their withdrawal periods, and obtaining signed statements from animal sources. The firm must respond within fifteen working days, detailing corrective actions and prevention measures, with failure to comply potentially leading to regulatory action such as injunction.