FDA WARNING_LETTER - Hilgenkamp Farm Inc - September 14, 2017

On November 15, 2017, the FDA issued a Warning Letter to Hilgenkamp Farms, Inc. following an investigation conducted on September 12-14, 2017, at their dairy operation in Arlington, NE. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a cow sold for slaughter on May 24, 2017, identified by ear tag 7691, was found to have desfuroylceftiofur (ceftiofur marker residue) at 6.691 ppm in kidney tissue (tolerance 0.4 ppm) and flunixin at 0.213 ppm in liver tissue (tolerance 0.125 ppm). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA also found insanitary conditions, leading to adulteration under section 402(a)(4). Deficiencies included: * Failure to maintain complete drug treatment records for cow 7691, and general records lacking condition treated, dosage, withdrawal times, administrator, or route of administration. * Failure to maintain an adequate drug inventory system (list of drugs, quantities, lot numbers, dates used, expiration dates). * Failure to segregate treated animals; treated animals were kept with non-treated