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  5. Great Lakes Cattle Marketing Company, LLC - 460743 - 05/21/2015
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WARNING LETTER

Great Lakes Cattle Marketing Company, LLC MARCS-CMS 460743 — May 21, 2015

Great Lakes Cattle Marketing Company, LLC - 460743 - 05/21/2015

Product:
Animal & Veterinary

Recipient:
Great Lakes Cattle Marketing Company, LLC


United States

Issuing Office:
Detroit District Office

United States


   

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, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139

 

WARNING LETTER
2015-DET-14
 
VIA UPS
 
May 21, 2015
 
 
Gary R. Labor, Partner
Stacy M. Barr, Partner
DeeAnn Fleming, Partner
Great Lakes Cattle Marketing Co., LLC
P.O. Box 60
St. Louis, MI 48880
 
Dear Mr. Labor, Mr. Barr, and Ms. Fleming:
 
On April 8, 14, and 23, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle sales operation located at 7758 N. Croswell, St. Louis, MI. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about May 12, 2014, you consigned a Holstein bull calf, identified with back tag (b)(4), RFID ear tag (b)(4), and ear tag (b)(4) for slaughter as food. On or about May 13, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 10.7 ppm florfenicol in the calf’s liver and 1.23 pm florfenicol in the calf’s muscle tissue. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the edible liver tissues of cattle and 0.3 ppm for residues of florfenicol in the edible muscle tissues and cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.283(b) (21 C.F.R. § 556.283(b)).
 
In addition, USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 1.72 ppm flunixin in the calf’s liver and 0.0277 ppm flunixin in the calf’s muscle tissue. FDA has established a tolerance of 125 ppb (0.125 ppm) for residues of flunixin in the edible liver tissues of cattle and 25 ppb (0.025 ppm) for residues of flunixin in the edible muscle tissues of cattle, as codified 21 C.F.R. § 556.286(b). The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Our investigation also found that your animals are held under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you consign your animals to be raised and medicated by contract farmers, but failed to ensure that your contractors maintain treatment records and segregate treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
 
We acknowledge receipt of your letter dated May 12, 2015, sent in response to the FDA 483. The letter includes a copy of treatment records for one of your contract farmers. However, we note that your letter does not state whether a system is in place for review of these records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed. Additionally, we note that the copy of the treatment record provided does not include the meat withdrawal time.
 
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 violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further 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 of receiving this letter, 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 Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207.
 
If you have any questions about this letter, please contact Compliance Officer Essary at 313-393-8150.
 
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office
 
 
cc:       
Ms. Melanie A. Hart
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division
HartM1@Michigan.gov
 

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