FDA WARNING_LETTER - Darr Feedlot Inc - December 17, 2009

This FDA Warning Letter, Ref. KAN 2010-04, was issued to Darr Feedlots Inc. following inspections on May 13-14, 2009, and December 15-17, 2009, at their Darr North and Darr South medicated feed mills in Cozad, Nebraska.

The inspections revealed the unapproved combination of new animal drugs, chlortetracycline and monensin, in cattle feed. This combination is contrary to their respective New Animal Drug Application (NADA) approvals (21 CFR 558.128 and 21 CFR 558.355), rendering the drugs unsafe (Section 512(a)(1)(A) of the Act) and adulterated (Section 501(a)(5) of the Act). The feed itself is also deemed unsafe (Section 512(a)(2)(B) of the Act) and adulterated (Section 501(a)(6) of the Act). Numerous instances of manufacturing this unapproved combination were documented at both facilities in May, June, and December 2009.

Additionally, significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 C.F.R. 225) were found, causing the medicated feed to be adulterated (Section