Inspections, Compliance, Enforcement, and Criminal Investigations
Wilbur Ellis Company 08-Jan-08
Department of Health and Human Services
Public Health Service
January 8, 2008
RETURN RECEIPT REQUESTED
John P. Thacher, President and CEO
345 California Street, 27th Floor
San Francisco, California 94104
In reply refer to Warning Letter SEA 08-08
Dear Mr. Thacher:
An inspection conducted by the Food and Drug Administration of your licensed medicated feed mill, Wilbur-Ellis Company, located at 312 Wenas Street, Ellensburg, Washington, on October 23, 24, and 26, 2007, found significant deviations from Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225)). These deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501 (a)(2)(B) [21 U.S.C. 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic-Act (the Act).
Our investigation found that your firm's manufacturing processes did not conform to the cGMP requirements. Our investigator observed the following deviations:
1. For medicated feeds requiring a medicated feed mill license, your facility at Ellensburg, Washington, did not 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:
a. At least [redacted] batches of medicated feed containing amprolium, a Category II, Type A medicated article were manufactured, but only one sample of medicated feed was submitted for amprolium analysis.
b. At least [redacted] batches of medicated feed containing pyrantel tartrate, a Category II, Type A medicated article were manufactured, but only two samples of medicated feed were submitted for pyrantel tartrate analysis.
c. At least [redacted] batches of medicated feed containing fenbendazole, a Category II, Type A medicated article were manufactured, but only two samples of medicated feed were submitted for fenbendazole analysis.
2. When results of laboratory assays of drug components indicated that a medicated feed was not in accord with permissible limits, your facility did not immediately implement an investigation and corrective action, or maintain a record on the premises of corrective action, as required by 21 C.F.R. 225.58(d). For example:
a. A sample (Formula # [redacted], Lot # 159312) was submitted for fenbendazole analysis on March 7, 2006, and this analysis found the sample to contain 69.0% of the theoretical level. This sample was resubmitted on May 1, 2006, and upon reanalysis the sample was found to contain 65.3% of the theoretical level. The assay limits for fenbendazole are [redacted]% of the theoretical level. No investigation or corrective actions were undertaken.
b. A sample (Formula # [redacted], Lot # 196161) was submitted for pyrantel tartrate analysis on September 20, 2006, and this analysis found the sample to contain 63.1% of the theoretical level. The assay limits for pyrantel tartrate are [redacted]% of the theoretical level. No investigation or corrective actions were undertaken.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct these violations and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) [21 U.S.C. 360b(m)(4)(B)(ii)] of the Act and 21 C.F.R. 515.22(c)(2).
Based on the results of the October 2007 inspection, evaluated together with the evidence before FDA when the Medicated Feed License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.
You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. Your response should include an explanation of each step being taken to correct the cGMP violation and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Form FDA 483
cc: Mr. Steve W. Johnson, Plant Manager
Wilbur-Ellis Company, 312 Wenas Street, Ellensburg, WA 98926
Dennis McDermott, Segment Manager, Livestock Nutrition
Wilbur-Ellis Company, 1200 N.W. Naito Parkway, Suite 140, Portland, Oregon 97209
All Kashani, Fertilizer and Feed Program,
Washington State Department of Agriculture
PO 42560, Olympia, Washington 98504-2560