# FDA WARNING_LETTER - Wilbur Ellis Company - October 26, 2007

Source: https://www.keypedia.com/records/warning_letter/wilbur-ellis-company/3c815fda-0a03-4d49-b6dd-357f64077b01

> FDA WARNING_LETTER for Wilbur Ellis Company on October 26, 2007. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wilbur Ellis Company
- Inspection Date: 2007-10-26
- Product Type: Food
- Office Name: Seattle District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/charles-m-breen/ea1c624f-6943-4e12-b826-4cffbf358220)

Company: https://www.keypedia.com/companies/wilbur-ellis-company/2fb83a1b-7d93-4a39-8448-9e47b3b853c1

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913