Inspections, Compliance, Enforcement, and Criminal Investigations
Western Ag Industries 25-Apr-06
Department of Health and Human Services
Public Health Service
Denver District Office
April 25, 2006
RETURN RECEIPT REQUESTED
Mr. Bryan K. Draper
Western Ag Industries
151 South Main St.
Genola, UT 84655
Ref # DEN-06-16
Dear Mr. Draper:
An investigation of your medicated feed distribution business, conducted by the U.S. Food and Drug Administration (FDA), on November 28, 2005, revealed that on several occasions since November 4, 2004, you purchased a Category IT, Type A medicated article (Amprolium 25%) from [redacted] and then sold it and had it delivered directly to [redacted] a firm that does not have a Medicated Feed Mill License.
Under section 512(a)(1) [21 U.S.C. § 360b(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act), a new animal drug is deemed unsafe, and therefore, adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)], if it is removed from a distributor's establishment for use in the manufacture of animal feed, unless at the time of such removal, the distributor has an unrevoked written statement from the consignee of the drug, or notice from the Secretary of Health and Human Services, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under section 512(m) [21 U.S.C. § 360b(m)) and possesses current approved labeling for such drug in animal feed or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under section 512(m) [2l U.S.C. § 360b(m)). Your firm had no such written statement on file from [redacted] the feed mill to which you sold and had delivered the new animal drug, Category II, Type A medicated article (Amprolium 25%)
Accordingly, the removal of the new animal drug, Category 11, Type A medicated article (Amprolium 25%) from [redacted] the for the manufacture of Type B medicated feeds by an unlicensed feed mill causes the new animal drug to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. fi 351(a)(5)] of the Act.
In addition, your own-label medicated feed "WESTERN AG INDUSTRIES AMPROLIUM CRUMBLES" is being manufactured by a firm without a Medicated Feed Mill License. The 50 lb bags of "WESTERN AG INDUSTRIES AMPROLIUM CRUMBLES" manufactured without a medicated feed mill license are unsafe under section 512(a)(2)(B) [21 U.S.C. § 360b(a)(2)(B)] of the Act and therefore adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to make immediate and fasting corrections may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office, in writing, within fifteen (15) working days of receiving this letter of the steps you have taken to achieve and maintain compliance with the law. Your response should be directed to: Food and Drug Administration, Denver District, P. 0. Box 25087, Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions, please contact Mr. Sherer at (303) 236-3051.
B. Belinda Collins