FDA WARNING_LETTER - Windy Ridge Dairy - July 21, 2011

An FDA inspection of Windy Ridge Dairy in Fair Oaks, IN, conducted from June 10 to July 21, 2011, confirmed the sale of an adulterated culled dairy cow for slaughter on August 11, 2010. Tissue samples from the animal revealed penicillin residue at 1.43 ppm, exceeding the established tolerance of 0.5 ppm (21 CFR 556.510). This rendered the food adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Food, Drug, and Cosmetic Act. The violations stemmed from the use of an approved drug contrary to its labeling and a failure to ensure appropriate withdrawal times, resulting in illegal residues. The FDA determined that the dairy holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. Specifically, the firm lacks a robust system to prevent such medicated animals from entering the food chain, which further contributes to adulteration under section 402(a)(4). The letter mandates prompt corrective actions and the establishment of procedures to prevent recurrence. Windy Ridge Dairy must respond in writing within fifteen working days, detailing specific steps taken or planned, with documentation, to address these serious compliance issues and avoid potential regulatory actions like seizure or injunction.