FDA WARNING_LETTER - Allandale Dairy - March 20, 2019

The FDA conducted an inspection of Allandale Dairy in Pierz, Minnesota, on March 13 and 20, 2019, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary concern is that the dairy holds animals under inadequate conditions, increasing the likelihood of medicated animals with potentially harmful drug residues entering the food supply. Specifically, the inspection revealed a failure to maintain a complete treatment record for penicillin administration to a cow identified with ear tag (b)(4). Furthermore, the firm's treatment records were deficient, lacking crucial information such as dosage, route of administration, number of injection sites, the person who administered the treatment, and the necessary withdrawal times for both meat and milk. Food from animals held under such conditions is considered adulterated under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4). Allandale Dairy is responsible for ensuring its operations comply with the law and must take prompt corrective action to address these violations and prevent recurrence. The FDA requires a written response within 15 working days detailing the steps taken or planned, including documentation, to achieve compliance. Failure to comply may result in regulatory actions such as seizure or injunction.