Inspections, Compliance, Enforcement, and Criminal Investigations
Wilbur Ellis Company 04-Apr-06
Department of Health and Human Services
Public Health Service
Denver District Office
April 4, 2006
RETURN RECEIPT REQUESTED
Mr. Herbert B. Tully
Wilbur Ellis Company
345 California Street, 27th Floor
San Francisco, CA 94104
Ref # DEN-06-13
Dear Mr. Tully:
An investigation of your licensed medicated feed mill, known as Knox McDaniel Company, 815 West 24th Street, Ogden, Utah, conducted by the U.S. Food and Drug Administration (FDA) on November 21 - 22, 2005, revealed that on four separate occasions,your facility sold a Category II, Type A medicated article (Amprolium 25%) to [redacted] a firm which does not hold a Medicated Feed Mill License.
The specific sales of Amprolium 25% to [redacted] were documented as follows: On [redacted] -50 lb bags were sold, covered by invoice [redacted] 50 lb bags were sold, covered by invoice [redacted] -50 lb bags were sold, covered by invoice [redacted], and on [redacted] -50 lb bags were sold, covered by invoice. At the direction of [redacted], the Category 11, Type A medicated article was shipped by a Knox McDaniel truck directly to [redacted] a firm which does not hold a Medicated Feed Mill License. [Redacted] used the Amprolium 25% to manufacture Type B medicated feeds for [redacted].
1. Under section 512(a)(1) [21 U.S .C. § 360b(a)(1)] of 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) [21 U.S.C. § 360b(m)]. Your firm had no such written statement on file from the feed mill to which you sold the new animal drug, Category 11, Type A medicated article (Amprolium 25%).
Accordingly, removal of the new animal drug, Category 11, Type A medicated article (Amprolium 25%) from your facility 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. § 351 (a)(5)) of the Act.
As a manufacturer of medicated and non-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 the above violations and to establish procedures whereby such violations do not recur. Failure to make immediate and lasting 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. O. 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