FDA WARNING_LETTER - Newberry Farms, LLC - July 15, 2010

On July 13 and 15, 2010, the FDA conducted an investigation of Newberry Farms, LLC's dairy operation, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated cow for slaughter (ear tag (b)(4)) that contained penicillin at 0.1 ppm, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. § 556.510(a)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. Additionally, the investigation found that animals were held under insanitary conditions, such as failing to maintain complete treatment records, making it likely that medicated animals with harmful drug residues would enter the food supply, a violation of section 402(a)(4) of the Act. A third violation involved providing a false "Livestock Owner Certificate" for the adulterated cow, which is prohibited by section 301(h) of the Act. Newberry Farms is required to take prompt action to correct these deficiencies and establish procedures to prevent recurrence. A written response detailing corrective actions and documentation is due within fifteen working days, with potential regulatory actions like seizure or injunction for non-compliance.