FDA WARNING_LETTER - Paulding Dairy LLC - March 20, 2015

On February 17, March 17, and March 20, 2015, the FDA investigated Paulding Dairy, identifying violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on September 30, 2014, was found to be adulterated. USDA/FSIS analysis of kidney tissue from this animal revealed 0.74 ppm of desfuroylceftiofur, exceeding the FDA tolerance of 0.4 ppm, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that Paulding Dairy held animals under insanitary conditions, specifically failing to maintain complete 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 FD&C Act.

Paulding Dairy 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. The FDA noted a March 30, 2015, response from Paulding Dairy, which lacked documentation of corrections. The company must provide a written response within fifteen working days, detailing corrective actions and a timeline for completion, including supporting documentation.