FDA WARNING_LETTER - Wilbur Ellis Company - October 26, 2007

On October 23, 24, and 26, 2007, the FDA inspected Wilbur-Ellis Company's medicated feed mill in Ellensburg, Washington, and found significant deviations from Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 C.F.R. Part 225). These deviations cause the manufactured feeds to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

The inspection revealed two primary violations: 1. The facility failed to perform assays on at least three representative samples of medicated feed containing each drug or drug combination during calendar year 2006, as required by 21 C.F.R. 225.58(b)(1). For example, only one sample was analyzed for amprolium despite multiple batches, and only two samples each for pyrantel tartrate and fenbendazole, falling short of the required three. 2. When laboratory assays indicated medicated feed was outside permissible limits, the facility did not immediately investigate, implement corrective action, or maintain records of such actions, violating 21 C.F.R. 225.58(d). Specific instances included fenbendazole and pyrantel tartrate samples found significantly below theoretical levels, with no investigation or corrective actions undertaken.

The FDA stated