FDA WARNING_LETTER - Elder Grove Dairy - April 18, 2013

On April 16 and 18, 2013, the FDA inspected Elder Grove Dairy, owned by James G. Rankel, in Colby, Wisconsin, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of adulterated bob veal calves for slaughter, which contained illegal residues of tilmicosin and gentamicin, exceeding established tolerances or lacking any tolerance (21 CFR 556.735(b)(1)), rendering the food adulterated under section 402(a)(2)(C)(ii). The investigation revealed the farm held animals under inadequate conditions, making it likely that medicated animals with harmful drug residues would enter the food supply, violating section 402(a)(4). Specific deficiencies included a failure to maintain treatment records for medicated calves and the absence of a reliable system to ensure drug withdrawal times were observed before slaughter. Furthermore, the firm adulterated new animal drugs, (b)(4) Tilmicosin Injection and Gentamicin Sulfate Solution, by using them extralabelly without following approved labeling or veterinarian directions. This extralabel use was not under the supervision of a licensed veterinarian (21 CFR 530.11(a)) and resulted in illegal drug residues for both tilmicosin (21 CFR 530.11(d)) and gentamicin (21 CFR 530.11(c)). The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. The firm must respond in writing within 15 working days, detailing corrective steps and timelines, or face potential regulatory actions like seizure or injunction.