FDA WARNING_LETTER - Lor-Rob Dairy Farm - August 22, 2012

On August 15, 17, and 22, 2012, the FDA inspected Lor-Rob Dairy Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a cow for slaughter on March 29, 2012, which was found to have 0.39 ppm of ampicillin in its kidney, exceeding the 0.01 ppm tolerance (21 C.F.R. 556.40). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed unsanitary conditions, including a failure to maintain complete treatment records, making food from such animals adulterated under section 402(a)(4). Furthermore, the farm adulterated the new animal drug (b)(4) (ampicillin) by using it extralabelly without following the veterinarian's prescribed duration of treatment, violating 21 C.F.R. 530.11(a). This non-conforming use caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

Lor-Rob Dairy Farm must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines is required