FDA WARNING_LETTER - John M. Mellott Farm - August 27, 2008

On August 26-27, 2008, the FDA investigated John Mellott Farm, a dairy operation. The investigation found violations of the Federal Food, Drug, and Cosmetic Act. Specifically, a bob veal calf sold for slaughter on February 14, 2008, and slaughtered on February 15, 2008, was found to have 8.42 ppm of neomycin in its kidney tissue, exceeding the FDA tolerance of 7.2 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act, as it contained an unsafe new animal drug.

Additionally, the farm was found to hold animals under insanitary conditions, specifically failing to maintain treatment records for medicated animals. This practice increases the likelihood of harmful drug residues entering the food supply, causing the food to be adulterated under section 402(a)(4) of the Act.

The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps, including documentation, is required within fifteen working days of receiving the letter. If corrections cannot be completed within this timeframe, a reason for delay and a new timeframe must be provided.