Rich-Lou Farms – FDA Warning Letter

On August 2, 2013, the FDA conducted an investigation of Rich-Lou Farms' dairy operation in Martinsburg, Pennsylvania, leading to a Warning Letter issued on September 24, 2013. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter, which contained penicillin residues at (b)(4) parts per million (ppm) in the kidney, significantly exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510), thus rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. The investigation also found that the farm held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, a violation of section 402(a)(4). A specific deficiency noted was the failure to maintain complete treatment records. Furthermore, the firm adulterated the new animal drug Penicillin G Procaine Injectable Suspension (NADA 065-505) through extralabel use not directed by its approved labeling. This extralabel use was conducted without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(d). These actions caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. Rich-Lou Farms is required to take prompt corrective action to address these violations and establish procedures to prevent their recurrence. A written response detailing these steps, including documentation, is due within fifteen working days. Failure to comply may result in further regulatory actions, such as seizure and/or injunction.