FDA WARNING_LETTER - Rangen Inc - June 11, 2009

On June 9-11, 2009, FDA investigators inspected Rangen, Inc.'s animal feed manufacturing facilities in Buhl, Idaho, revealing significant deviations from 21 CFR 589.2000, "Animal Proteins Prohibited in Ruminant Feed," intended to prevent Bovine Spongiform Encephalopathy (BSE). The inspection found products were adulterated under section 402(a)(4) and misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

Specifically, Rangen failed to implement adequate cleanout procedures to prevent carry-over of mammalian tissue proteins into animal feed for ruminants (21 CFR 589.2000(e)(1)(iii)(B)). Mink feed, potentially fed to ruminants, was produced on equipment also used for aquaculture feed containing mammalian proteins (e.g., meat and bone meal) without proper cleanouts. Additionally, auger trucks delivering bulk mink feed with mammalian proteins were not effectively cleaned before transporting other animal feeds, including ruminant feed.

Furthermore, Rangen failed to label all products containing or potentially containing mammalian tissue proteins with the required statement, "Do not feed to cattle or other ruminants" (21 CFR 589.2000(e)(1)(i)). This misbranded bulk mink feed, including lot 06/05