FDA WARNING_LETTER - Pastime Lakes Dairy L.P. - September 21, 2010

On August 26 and September 21, 2010, the FDA inspected Pastime Lakes Dairy in Lakeview, California, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated cow for slaughter, identified by ear tag 2284, which contained 0.162 ppm of flunixin in liver tissue, exceeding the 0.125 ppm tolerance (21 C.F.R. § 556.286), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the dairy was found to hold animals under inadequate conditions, such as failing 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 new animal drugs Polyotic Soluble Powder and Flunazine Injectable Solution were also adulterated due to extralabel use. Specifically, these drugs were not used as directed by their approved labeling (21 C.F.R. § 530.3(a)), and their extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. § 530.11(a)). The extralabel use of flunixin meglumine also resulted in illegal drug residues (21 C.F.R. § 530.11(d)), causing the drugs to be unsafe and adulterated under section 501(a)(5) of the FD&C Act. Pastime Lakes Dairy must take prompt corrective actions and establish procedures to prevent recurrence. A written response detailing these steps, with documentation, is required within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.