FDA WARNING_LETTER - Masselink Dairy Farm, LLC

On October 28, 2014, the FDA inspected Masselink Dairy Farm, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on June 12, 2014, was found to have 8.42 ppm of desfuroylceftiofur (a ceftiofur marker) in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically inadequate record-keeping, leading to adulterated food under section 402(a)(4). Treatment records for the aforementioned cow, treated with Excenel (ceftiofur) on June 10, 2014, failed to include dosages, administration routes, administering personnel, and withdrawal period end dates. The cow was sold two days after treatment, within the 4-day meat withhold period.

Masselink Dairy Farm's December 3, 2014, response acknowledged changes to record-keeping, including reinstating handwritten records and reviewing drug labels. However, the FDA noted that an animal was still released within the withdrawal time despite these changes, and no supporting documentation for proposed corrections was provided.