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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Bakery Trading Company 29-Jul-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
Kansas City District
Southwest Region
11630 West 60 Street
P.O. Box 15905
Lenexa, Kansas 66265-4905
Telephone: (913) 752-2100

July 29, 2002
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2002-09

Jerry Behimer, Owner
Bakery Trading Company/Ingredient Exchange
401 N. Lindbergh Blvd., Suite 315
St. Louis, MO 63141-7816

Dear Mr. Behimer:

An inspection of your animal feed premix-manufacturing operations, located at 14521 2nd Ave., Ottumwa, Iowa, was conducted by an Investigator from our office on June 18 & 19, 2002. During this inspection, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed was identified. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Under 21 C.F.R. 589.2000(g)(2), such a deviation causes products being manufactured and/or distributed by your facility to be deemed misbranded within the meaning of Section 403(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act), and these products may not be lawfully introduced, or delivered for introduction, into interstate commerce.

Our investigation found a failure to label your Powdered Cooked Beef, Product No. 5013, produced during the period of 2/13/02 to approximately 4/18/02, with the cautionary statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 C.F.R. 589.2000(d). The FDA suggests the statement be distinguished by different type size or color, or other means of highlighting the statement so that it is easily noticed by a purchaser.

The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, 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 this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

It is necessary for you to take action on this matter now. We request you provide our office documentation of corrective action and final disposition for Lot 030402, approximately 21 tons, which was on hand during the inspection. Let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problem.

Your reply should be sent to Nadine Nanko Johnson, Compliance Officer, at the above address.

Sincerely,

/s/

Charles W. Sedgwick

District Director

Kansas City District