FDA WARNING_LETTER - Irish Acres Dairy LLC - August 20, 2010

On October 14, 2010, the FDA issued a Warning Letter to Irish Acres, LLC, following an investigation of their dairy operation in Berne, Indiana, conducted on August 6, 11, 19, and 20, 2010. The letter identifies violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a cow sold for slaughter on April 29, 2010, and slaughtered on April 30, 2010, was found to have sulfadimethoxine residues of 0.578 ppm in liver and 0.272 ppm in muscle tissues. This exceeds the FDA tolerance of 0.1 ppm, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the investigation revealed insanitary conditions, including a failure to maintain complete treatment records for medicated animals. This indicates that animals with potentially harmful drug residues are likely to enter the food supply, causing the food to be adulterated under section 402(a)(4) of the Act.

Irish Acres, LLC, is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions, including documentation, must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure or