Western Milling Company – FDA Warning Letter, Mar 31, 2010

An FDA inspection of Western Milling Company's Phoenix, Arizona facility from March 18-31, 2010, initiated due to a dairy farm complaint, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for medicated feeds (21 C.F.R. Part 225). These deviations caused the manufactured animal feed to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm failed to implement adequate safeguards to prevent unsafe contamination in medicated and non-medicated feeds (21 C.F.R. 225.165). For example, the written cleanout procedure for medicated feeds was insufficient, directing the use of "(b)(4)" as a flush and mentioning "sequencing" without explanation or a written plan.

Additionally, labeling deviations caused certain animal feed products to be misbranded under section 403(a)(1) of the Act. Specifically, medicated animal feeds lacked adequate labeling (21 C.F.R. 225.180). Customer-formula medicated feeds, such as a dairy feed containing "(b)(4)" manufactured on "(b)(4)", had delivery invoices and "LOAD IT SHEETs" that omitted required drug information, including directions-for-use, as per 21 C.F.R