FDA WARNING_LETTER - Central Connecticut Cooperative Farmers Association - February 08, 2008

On January 25 and February 8, 2008, the FDA inspected Central Connecticut Cooperative Farmers Association's licensed medicated feed mill in Manchester, Connecticut. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, samples of the firm's 12% Equinator Integrity Horse Pellets, BH617, were found to contain unapproved new animal drugs, [redacted] (lasalocid sodium) and salinomycin, which are not approved for equine feed. Consequently, this equine feed is deemed unsafe under section 512(a)(2) [21 U.S.C. § 360b(a)(2)] and adulterated under section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act. The firm's February 21, 2008 response to the Inspectional Observations (Form FDA-483) was deemed inadequate as it lacked specific information on preventing recurrence, particularly regarding equipment cleaning procedures. The FDA requires prompt corrective action and establishment of procedures to prevent future violations. The firm must notify the FDA in writing within fifteen working days, detailing specific steps taken, explanations of corrections, and recurrence prevention measures, including documentation. Failure to correct these violations may lead to regulatory sanctions such as seizure or injunction.