FDA WARNING_LETTER - Graham Farms - May 01, 2009

The FDA conducted an inspection of The Graham Farm's dairy operation on April 29 and May 1, 2009, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of an adulterated calf for slaughter, which was found to contain 126.95 ppm of sulfamethazine in its liver tissue, far exceeding the 0.1 ppm tolerance (21 C.F.R. 556.670). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act. Further investigation revealed the farm held animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4). Specific deficiencies included failure to maintain complete treatment records. Additionally, the new animal drug sulfamethazine (NADA 120-615) was found to be adulterated due to extralabel use not directed by its approved labeling (21 C.F.R. 530.3(a)). This included administering the drug to calves under one month of age without a licensed veterinarian's order (21 C.F.R. 530.11(a)) and resulting in illegal residues (21 C.F.R. 530.11(d)). These extralabel uses rendered the drug unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act. The firm is required to take prompt corrective action, establish preventative procedures, and respond in writing within fifteen working days, or face potential regulatory actions like seizure or injunction.