Inspections, Compliance, Enforcement, and Criminal Investigations
West Feeds, Inc. 24-May-06
Department of Health and Human Services
Public Health Service
May 24, 2006
RETURN RECEIPT REQUESTED
Gil Carrier, President
West Feeds, Inc.
1420 Minnesota Avenue
Billings, MT 59101
In reply refer to Warning Letter SEA 06-32
Dear Mr. Carrier:
An inspection conducted by the Food and Drug Administration of your licensed medicated feed mill located at 921 15th Street North, Great Falls, Montana, on February 28, March 2-3, and 6, 2006, found significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Your firm used the Category II, Type A medicated article amprolium in Type B or Type C medicated feeds containing bentonite. Amprolium is not approved for use in Type B or Type C medicated feeds that contain bentonite. This use causes the new animal drug amprolium to be deemed unsafe within the meaning of section 512(a)(1) [21 U.S.C. § 360b(a)(1)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, this use of amprolium to produce medicated feed causes the medicated feed to be unsafe under section 512(a)(2) [21 U.S.C. § 360b(a)(2)] of the Act and adulterated under section 501(a)(6) [21 U.S. C. § 351(a)(6)] of the Act.
Your firm also fails to conduct potency assays on at least three representative samples, at periodic intervals during the calendar year, of each feed required to be manufactured by a licensed feed mill as required by 21 CFR Section 225.58(b)(1). Specifically, your Great Falls facility manufactured at least [redacted] batches of medicated feed containing amprolium, a Category II, Type A medicated article, during calendar year 2005 without performing the required assays. This failure to comply with the Current Good Manufacturing Practice (CGMP) regulations causes medicated feeds manufactured at this facility to be adulterated within the meaning of section 501 (a)(2)(8) [ 21 U.S.C. § 351 (a)(2)(13)] of the Act.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated feeds, you are responsible for ensuring 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). This letter constitutes official notice under the law. Based on the results of the inspection which concluded March 6, 2006, 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 drugs therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
You should notify this office, in writing, within 15 working days of receiving this letter of the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations 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: Lisa M. Brand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding this letter, please contact Ms. Elrand at (425) 483-4913.
Charles M. Breen