FDA WARNING_LETTER - Stardust Dairy, LLC - November 20, 2009

The FDA conducted an inspection of Stardust Dairy, LLC, owned by Franciscus X.J. Van Genugten, from October 16 to November 20, 2009, at their South Solon, OH facility. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering an adulterated animal for slaughter as food. Specifically, a cow with ear tag (b)(4), slaughtered on April 21, 2009, was found to have Flunixin residue in its liver at 0.1689 ppm, exceeding the established tolerance of 0.125 ppm (21 CFR 556.286), rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Furthermore, the investigation identified that Stardust Dairy holds animals under inadequate conditions, increasing the risk of medicated animals with potentially harmful drug residues entering the food supply. This constitutes adulteration under 21 U.S.C. 342(a)(4). Deficiencies included a lack of an adequate inventory system for drug quantities and incomplete drug treatment records for medicated animals. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Stardust Dairy must submit a written response within fifteen working days, detailing all corrective steps taken or planned, including documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.