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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Duane Oxendale 26-Sep-07

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

Public Health Service
Food and Drug Administration

 

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 26, 2007

WARNING LETTER
2007-DT-10

Mr. Duane K. Oxendale, Owner
Duane Oxendale
301 Wilson
St. Louis, Michigan 48880

Dear Mr. Oxendale:

An investigation of your beef finishing operation located at 5751 Redstone Road, St. Louis, Michigan 48880, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 21 and 27, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug,and Cosmetic Act (the Act). The inspection also revealed that you provided a false guaranty, a prohibited act under section 301(h) [21 U.S.C. 331(h)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On Apri1 30, 2007, you sold a heifer through [redacted] where it was identified with back tag number 34SL6213, subsequently sold to [redacted] where it was slaughtered for human food use on June 2, 2007. United States Dept. of Agriculture/Food Safety Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 40.96 parts per million (ppm) sulfamethazine in the liver and 23.91 ppm sulfamethazine in the muscle of this cow. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 (21 C.F.R. 556.670). The presence of sulfamethazine in these amounts in the edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342 (a)(4)]of the Act.

In addition, on or about January 2, 2007, you provided [redacted] with a signed certification, which states that you will not supply [redacted] with any livestock that contains illegal levels of drug residues. On April 30, 2007, you delivered to [redacted] a culled heifer cow containing illegal levels of sulfamethazine residues. Providing such a false guaranty is a prohibited act under section 301(h) [21 U.S.C. 331(h)] of the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as a seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving of this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Ms. Judith Jankowski, Compliance Officer, U.S. Food and Drug Administration at 300 River Place Dr. Suite 5900 Detroit, MI 48207. If you have any, questions about this letter, please contact Compliance Officer Jankowski at 313-393-8125.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office