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  5. MGM Cattle Co. LTD - 07/29/2015
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WARNING LETTER

MGM Cattle Co. LTD Jul 29, 2015

MGM Cattle Co. LTD - 07/29/2015

Product:
Animal & Veterinary

Recipient:
MGM Cattle Co. LTD


United States

Issuing Office:
Dallas District Office

United States


   

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

Public Health Service
Food and Drug Administration
 

Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204·3128 

 

July 29, 2015
 
2015-DAL-WL-24
 
WARNING LETTER
 
UPS Overnight
                                                                                                     
 
Patrick C. Mackle, Feedlot Manager and Partner
MGM Cattle Company, Ltd.
12811 E. Highway 90
Kingsbury, Texas 78638
 
Dear Mr. Mackle:
 
On June 4 - 8, 2015 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12811 E. Highway 90, Kingsbury, Texas 78638. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 November 30, 2014, you sold a cow, identified with tag (b)(4) for slaughter as food. On or about December 1, 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 2.32 parts per million (ppm) of flunixin in the liver, 16.58 ppm of desfuroylceftiofur (marker residue for ceftiofur) in the kidney, and 0.31 ppm of florfenicol in the muscle. FDA has established a tolerance of 125 parts per billion (ppb) (0.125 ppm) for residues of flunixin, 0.4 ppm for residues of desfuroylceftiofur, and 0.3 ppm of florfenicol in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. 556.286), 21 C.F.R 556.113, and 21 C.F.R. 556.283; respectively. The presence of these drugs in edible tissues from this animal in these amounts cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
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. For example, your firm failed to maintain treatment records for animals treated prior to December 28, 2014 and the treatment records you did maintain did not identify the route of administration or withdrawal times for the treatments. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
Our investigations also revealed that on November 30, 2014, your employee provided (b)(4), a signed certification stating that the livestock you sell do not have illegal levels of drug residues. On November 30, 2014, you delivered a cow identified with tag (b)(4), which contained violative residues of flunixin, desfuroylceftiofur, and florfenicol, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
We have received your written response dated June 12, 2015. Our review determined your response is inadequate. Your response does not address how you will ensure the appropriate treatment information is documented in your treatment records. Further, although you have committed to disposing of the expired drug products, you did not propose your process for drug inventory control to prevent expired product from being available for use in the future.
 
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 Jeff R. Wooley, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
cc:       Claire Madden, Office Manager and Partner
MGM Cattle Company, Ltd.
12811 E. Highway 90
Kingsbury, Texas 78638
 
Texas Department of State Health Services
Lewis Ressler
Food Program Manager
Exchange Building
8407 Wall Street
Austin, TX 78754
 
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598