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WARNING LETTER WL-CIN-7703-01


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-7703-01 September 20, 2001

CERTIFIED MAIL RETURN RECEIPT REQUESTED

William P. Herrington, President Buckeye Feed Mills, Inc. (dba) Buckeye Nutrition 330 East Schultz Avenue Dalton, OH 44618

Dear Mr. Herrington:

Food and Drug Administration (FDA) investigators conducted an inspection of your feed mill from April 5-24, 2001. The inspection found significant and serious deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). These deviations caused products manufactured by your firm to be adulterated and misbranded.

The violations are as follows:

Our investigators documented that you did not flush or sequence the incoming receiving pit conveyor systems and ingredient storage bins after the receipt of ruminant meat and bone meal to avoid contamination of ingredients that were used in ruminant feeds.

Further, the investigators found that your firm failed to label feeds that contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants".

There are no written procedures for cleaning out or flushing the receiving pit conveyor system and ingredient storage bins. Additionally, you do not have records documenting that the system was cleaned or flushed in accordance with any written procedures.

Your procedure for sequencing/flushing of the mixers (MOP-004 rev. date 2/2/98) allows for feeds containing ruminant meat and bone meal to be followed by horse and rabbit feeds that should bear the cautionary statement but do not.

Page I

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http://www.fda.gov/foi/warning_letters/g1779d.pdf


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