Marcellina Dairy – FDA Warning Letter, Nov 30, 2012

On December 26, 2012, the FDA issued a Warning Letter to Marcellina Dairy, LLC, following an investigation from November 26-30, 2012. The investigation found that the dairy offered adulterated animals for slaughter. Specifically, a dairy cow slaughtered on August 8, 2012, had 2.105 ppm of Sulfamethazine in its liver tissue, exceeding the FDA tolerance of 0.1 ppm (21 CFR 556.670). This violates section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].

Furthermore, the FDA found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Marcellina Dairy failed to maintain an adequate system to ensure appropriate withdrawal periods for medicated animals and did not keep complete and accurate treatment records. This constitutes adulteration under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

The FDA required prompt corrective action to prevent recurrence, warning of potential regulatory actions like seizure or injunction. Marcellina Dairy was instructed to respond in writing within fifteen working days, detailing steps taken or planned, including documentation such as written procedures and records.