Inspections, Compliance, Enforcement, and Criminal Investigations
West Feeds, Inc. 01-Apr-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
Don Cloud, CEO
West Feeds, Inc.
1420 Minnesota Avenue
Billings, Montana 59101
April 1, 2005
In reply refer to Warning Letter SEA 05-17
Dear Mr. Cloud:
An inspection conducted by the Food and Drug Administration of your medicated feed mill located at 512 North 7 Street, Miles City, Montana, on November 30 and December 1, 2004, found a significant deviation from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225 (21 CFR 225)) and the New Animal Drugs for Use in Animal Feeds regulation, 21 CFR 558. This deviation causes medicated feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) and 501(a)(6) of the Federal Food, Drug, and Cosmetic Act (the Act). The deviations are as follows:
1. You must possess a medicated feed mill license in order to manufacture medicated feeds from a Category 11, Type A medicated article, to comply with 21 CFR 558.4(a). However, our inspection disclosed that you do not possess a medicated feed mill license for your mill at 512 North 7 Street, Miles City, Montana, even though you utilize Category II, Type A medicated articles in the manufacture of medicated feeds and supplements at that facility. Specifically, you use the Category II, Type A medicated articles amprolium, sulfamethazine, and chlortetracycline in the manufacture of medicated feeds at your Miles City facility.
2. On an annual basis you must conduct periodic assays on at least three samples of medicated feeds requiring a medicated feed mill license, for each drug or drug combination used, to comply with 21 CFR 225.58(b)(1). You have not performed the required assays on the applicable medicated feeds and supplements at your Miles City facility . Specifically, your facility in Miles City, Montana, has manufactured medicated supplements containing the Category II, Type A medicated articles amprolium, sulfamethazine, and chlortetracycline since October 2003, without performing the required annual assays on at least three samples of applicable medicated feeds, for each drug or drug combination used.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of 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 actions without further notice to you. These actions include, but are not limited to, seizure and/or injunction.
You should notify this office in writing, within 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 recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within 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