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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Stewart, Ronnie R. 05-Jun-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 56401
Telephone: (612) 334-4100
FAX: (612) 334-4134


June 5, 2003

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 03 - 24

Mr. Ronnie R. Stewart
14047 Flintwood Court
Apple Valley, Minnesota 55124

Dear Mr. Stewart:

On April 21, 2003, an investigator from the Food and Drug Administration (FDA) conducted an investigation of your cattle operation in Apple Valley, MN. That investigation confirmed that three animals sold by you, for slaughter for human food, were in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).

USDA/FSIS analysis of tissues collected from cattle sold by you and slaughtered at [redacted] disclosed the presence of the following drugs:

Black Tag No.

Date Collected

Drug

Tissue

Level

Tolerance

       

----(ppm)-

---

41NE0594 BT

10/18/02

Flunixin

Liver

00.219

.125

41NE0592 BT

10/18/02

Sulfadimethoxine

Liver

01.76

.1

 

10/18/02

Sulfadimethoxine

Muscle

01.08

.1

41NC9263 BT

12/26/02

Penicillin

Kidney

00.11

.05

Tolerance levels for residues of animal drugs in foods are found in Title 21, Code of Federal Regulations, Part 556 (21 CFR 556). Tolerance levels for Flunixin, Sulfadimethoxine and Penicillin are in 21 CFR 566.286, 21 CFR 556.640, and 21CFR 556.510, respectively. The presence of these drugs, at levels above the tolerances, in edible tissue from these animals causes the food to be adulterated pursuant to Section 402(a)(2)(C)(ii) of the Act.

Our investigation found that you hold animals under conditions that are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. As noted on the form FDA-483 issued to you on April 21, 2003, you do not have adequate controls in place to prevent medicated animals from being purchased and sold for human food, and you do not keep records to permit traceability to the source of the animals. Foods from animals held under such conditions are adulterated pursuant to Section 402(a)(4) of the Act.

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

The violations discussed above are not intended to be an all-inclusive list. It is your responsibility to ensure that your operations are in compliance with the law. To avoid future residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;

2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and

3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

You should notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 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 reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.

Sincerely,
/s/
W. Charles Becoat
Director
Minneapolis District