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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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S & M Farm Supply 09-Apr-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215

Telephone: (410) 779-5454


FEI: 3004094116

04-BLT-13

April 9, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Steven D. Stratton, Owner
S & M Farm Supply
Route I Box 428A Mud River Road
West Hamlin, West Virginia 25571

Dear Mr. Stratton:

On January 5, 8. and 12. 2004, an investigator from the Food and Drug Administration (FDA) inspected your feed mill operation located at Route 1, Box 428A, Mud River Road, West Hamlin, West Virginia 25571. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, section 5.89.2000, "Animal Proteins Prohibited in Ruminant Feed" (21 CFR 589.2000). The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).

Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants." This is required by 21 CFR 589.2000(d)(1) and (c)(1)(i). Our inspection found that you are not labeling your product "GAMFBIRD MIX" with this caution statement. As a result, these products are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

During the inspection, FDA's inspector also found that your firm did not maintain records sufficient to track prohibited materials throughout their receipt, processing, and distribution as required by 21 CFR 589.2000(d)(1) and (c)(1)(ii). Your firm failed to document the date and quantity of "GAMEBIRD MIX" produced.

The above is not intended to he an all-inclusive list of deviations from the regulations. As a feed manufacturer of materials intended for animal feed use, 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 a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice. These actions include, but are not limited to, seizure and/or injunction. Please provide this office a written response within 15 working days of receipt of this letter with the 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 taken within 15 working days, state thc reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be submitted to: Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, to the attention of Elizabeth A. Laudig, Compliance Officer at (410) 779-5441.

Sincerely,

/S/

Lee Bowers
Director, Baltimore District