FDA WARNING_LETTER - Monica Farms, LLC - December 12, 2013

On December 3 and 12, 2013, the FDA inspected Monica Farms, LLC, a dairy operation in North Bangor, New York, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that the firm sold a dairy cow for slaughter with penicillin residues of 0.085 ppm in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510(a)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the firm held animals under insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4). The FDA also found that Monica Farms adulterated the new animal drug (b)(4) through extralabel use. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(d). Consequently, the drug was rendered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act due to non-conformance with approved labeling and 21 C.F.R. Part 530. Monica Farms is required to take prompt corrective action, establish preventative procedures, and notify the FDA in writing within fifteen working days, detailing steps taken or planned to achieve compliance and prevent recurrence, or face potential regulatory actions like seizure or injunction.