FDA WARNING_LETTER - Cargill, Inc. - February 27, 2008

An FDA inspection of Cargill, Inc.'s medicated feed mill in Billings, Montana, from February 25-27, 2008, revealed significant deviations from cGMP regulations for Medicated Feeds (21 C.F.R. Part 225), rendering manufactured feeds adulterated. Additionally, Llama Mineral feed contained unapproved chlortetracycline, making it unsafe and adulterated.

The firm's March 13, 2008, response to the FDA-483 was deemed insufficient. Key violations include: 1. Failure to investigate and implement corrective actions for out-of-limit medicated feed assays (e.g., sulfamethazine levels 24.4-26% above potency in cattle feed, with 7-10 month delays in investigation), violating 21 C.F.R. 225.58(d). 2. Failure to discontinue distribution of medicated feeds that failed potency assays, violating 21 C.F.R. 225.58(e). 3. Inadequate cleanout procedures, leading to unsafe cross-contamination. Examples include chlortetracycline in Nutrena Naturewise Lamb and Sheep Feed (up to 10 times labeled potency), Nutrabeef Cattle Grower Feed (4.8 ppm), Miller FDLT 45/27 (88.