FDA WARNING_LETTER - Reeder Farms - October 23, 2014

The FDA issued a Warning Letter to Reeder Farms following an inspection from October 7-23, 2014, at their dairy operation in Ionia, Michigan. The investigation revealed two primary violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). First, the firm offered for sale an adulterated dairy cow for slaughter on March 6, 2014. Tissue analysis by USDA/FSIS found desfuroylceftiofur residues at 4.05 ppm in the kidney, significantly exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113(b)(3)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Second, the FDA found that Reeder Farms holds animals under inadequate conditions, increasing the likelihood of medicated animals bearing harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. A specific deficiency noted was the failure to maintain complete treatment records. The FDA acknowledged the firm's October 24, 2014, response to the Form FDA 483, where Reeder Farms accepted responsibility and outlined new treatment record procedures. However, the FDA noted that despite previous limited documentation, an animal was released within its withdrawal time without proper record. Reeder Farms must take prompt corrective action and establish preventative procedures, notifying the FDA within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.