FDA WARNING_LETTER - Land Dairy, Inc. - January 14, 2010

On January 13-14, 2010, the FDA conducted an investigation of Land Dairy, Inc. in Mayo, Florida, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an animal for slaughter as food that was adulterated, specifically a dairy cow sold on August 6, 2009, which contained 0.2 ppm sulfamethazine in its liver tissue. FDA has not established a tolerance for sulfamethazine residues in lactating dairy cows, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also revealed that animals were held under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. § 342(a)(4). This was due to failures in maintaining complete treatment records, records documenting the identity of sold dairy cows, and an inventory system for drugs. Furthermore, the new animal drug sulfamethazine (NADA 120-615) was adulterated due to extralabel use. The firm administered sulfamethazine oral boluses to female dairy cattle 20 months or older, contrary to approved labeling. Extralabel use of sulfamethazine is prohibited in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9), and this use resulted in an illegal drug residue, violating 21 C.F.R. § 530.11(c), causing the drug to be unsafe and adulterated. Land Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions is required within fifteen working days, with potential regulatory actions like seizure or injunction if compliance is not achieved.