FDA WARNING_LETTER - Dream Farms - November 21, 2012

On November 21, 2012, the FDA inspected Dream Farms, a heifer calf and cow raising operation in Newburg, PA, and found violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that on January 9, 2012, Dream Farms sold a heifer veal calf for slaughter, which was found to contain Tulathromycin residues by USDA/FSIS analysis. There is a zero tolerance for Tulathromycin in veal calf tissues, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the FDA found that Dream Farms held animals under insanitary conditions, specifically failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the Act.

Dream Farms is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to do so may result in regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter.