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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Johnson Dairy 29-Feb-08

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

Public Health Service
Food and Drug Administration

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
61th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


February 29, 2008

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. John D. Johnson
Owner
Johnson Dairy
23016 Weld County Rd. 74
Eaton, CO 80615

Ref. #: DEN-08-11

Dear Mr. Johnson:

An inspection of your dairy operation located at 23 016 Weld County Road 74, Eaton, Colorado, conducted by a representative of the U.S. Food and Drug Administration(FDA) on November 11 - December 5, 2007, confirmed that you offered animals for sale for slaughter as food that were 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).

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 May 5, 2007, you sold a Holstein cow, with no identifying mark or tag, but later identified by United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) as [redacted], for slaughter as food at [redacted] On or about May 5, 2007, this animal was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.061 parts per million (ppm) Flunixin in the muscle tissue and 0.570 ppm Flunixin in the liver tissue. A tolerance of 0.025 ppm has been established for residues of Flunixin in the edible muscle tissues of cattle, and a tolerance of 0.125 ppm has been established for residues of Flunixin in edible liver tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. § 556.286). The presence of this drug in these amounts in 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.

On July 26, 2007, you sold a Holstein cow, identified with your mark, [redacted], and later identified by USDA/FSIS as [redacted], for slaughter as food at [redacted] On or about July 26, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.12 ppm Sulfadimethoxine in the liver tissue. A tolerance of 0.10 ppm has been established for residues of Sulfadimethoxine in the liver tissue of cattle, as codified in 21 C.F.R. § 556.640. The presence of this drug in this amount in edible tissue 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.

On August 17, 2007, you sold a Holstein cow, with your mark, [redacted], and later identified by USDA/FSIS as [redacted] for slaughter as food at [redacted] On or about August 17, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.341 ppm Flunixin in the liver tissue. A tolerance of 0.125 ppm has been established for residues of Flunixin in liver tissue of cattle, as codified in 21 C.F.R. § 556.286. The presence of this drug in this amount in edible tissue 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.

On September 21, 2007, you sold a Holstein cow, with your mark, [redacted], and later identified by USDA/FSIS as [redacted], for slaughter as food at [redacted] On or about September 21, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.270 ppm Flunixin in the muscle tissue and 4.912 ppm Flunixin in the liver tissue. A tolerance of 0.025 ppm has been established for residues of Flunixin in the muscle tissue of cattle, and a tolerance of 0.125 ppm has been established for residues of Flunixin in liver tissue of cattle, as codified in 21 C.F.R. § 556.286. The presence of this drug in these amounts in 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.

Delivery DateDairy IDUSDA IDSlaughter DateDrugTissueResidueTolerance

5/9/07

[redacted]

[redacted]

5/9/07

Flunixin

Muscle

Liver

0.061 ppm

0.570 ppm

0.025 ppm

0.125 ppm

7/26/07

[redacted]

[redacted]

7/26/07

Sulfadimethoxine

Liver

0.12 ppm

0.10 ppm

8/17/07

[redacted]

[redacted]

8/17/07

Flunixin

Liver

0.341 ppm

0.125 ppm

9/21/07

[redacted]

[redacted]

9/21/07

Flunixin

Muscle

Liver

0.270 ppm

4.912 ppm

0.025 ppm

0.125 ppm

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 forappropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete 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.

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 the above. violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without farther notice such as 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 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 William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Sherer at the above address, via telephone at (303) 236-3051, or by email at williarn.sherer@fda.hhs.gov.

Sincerely,

/S/

H. Thomas Warwick
Denver District Director

cc:
Ronald C. Nelson, D.V.M.
Denver District Director
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225