FDA WARNING_LETTER - Hillcrest Dairy - July 15, 2014

On July 14-15, 2014, the FDA inspected Hillcrest Dairy in Gettysburg, PA, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on August 14, 2013. USDA/FSIS analysis of tissue samples from this animal revealed desfuroylceftiofur, a metabolite of ceftiofur, at 0.62 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. § 556.113). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation found that Hillcrest Dairy held animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. This included a failure to maintain and review treatment records and adhere to withdrawal timeframes, constituting adulteration under section 402(a)(4) of the Act.

The FDA acknowledged Hillcrest Dairy's July 21, 2014, response to the FDA-483, but deemed it inadequate due to vagueness and lack of documentation for implemented corrections. Hillcrest Dairy is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and