FDA WARNING_LETTER - Hirsch's Dairy Farm - September 25, 2014

On September 12, 17, 24, and 25, 2014, the FDA investigated Hirsch's Dairy Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated bob veal calf for slaughter. Specifically, tissue samples from a calf sold on or about (b)(4) and slaughtered on or about (b)(4) contained sulfamethoxazole in the kidney. FDA has not established a tolerance for sulfamethoxazole residues in veal, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

Furthermore, the investigation revealed insanitary conditions, specifically the failure to maintain complete treatment records for medicated animals. This inadequacy suggests that animals bearing potentially harmful drug residues are likely to enter the food supply, causing food to be adulterated under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

Hirsch's Dairy Farm is responsible for ensuring compliance and must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure and/or injunction. A written response detailing corrective actions and timelines is required within fifteen