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  5. MGM Cattle Co. LTD - 05/27/2016
  1. Warning Letters

WARNING LETTER

MGM Cattle Co. LTD

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 

 

May 27, 2016
 
2016-DAL-WL-23
 
WARNING LETTER
United Parcel Service
         
 
 
Mr. Liam Madden, Co-Owner
MGM Cattle Company, Ltd.
Sallaghan
Loch Gowna
County Cavan
Republic of Ireland
 
Dear Mr. Madden:
 
On February 4, 5, 9, and 11, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 12811 E. Highway 90, Kingsbury, Texas 78638-2644. 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 17, 2015, you sold a Heifer cow identified with ear tag #(b)(4), for slaughter as food. On or about November 17, 2015, (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 0.632 parts per million (ppm) of flunixin residue in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (21 C.F.R. 556.286). The presence of this drug in edible tissues from this animal in this amount causes 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, you failed to maintain complete treatment records. Your firm’s treatment record from November 11, 2015 through November 16, 2015 failed to identify the route of administration for each drug given to the animals and your record does not identify the individual providing the treatment. 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).
 
We also found that you adulterated the new animal drug, (b)(4), ANADA (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by their approved labeling and/or by the veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 
 
Our investigation found that you administered (b)(4), ANADA (b)(4)) to a Heifer cow identified with ear tag #(b)(4) 8246 for treating conditions (pain due to injury or swelling) not stated on the approved labeling. Your extra label use of VetaMeg was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
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. 
 
We have received your written response dated March 1, 2016. Our review determined your response is inadequate. Your response included a revised treatment record which differentiates between intramuscular and intravenous administration. However, your firm also uses drugs which require subcutaneous and oral routes of administration. Your failure to recognize this as part of your response further brings into question the adequacy of the retraining that was provided to your cowboys on using the correct route of administration.
 
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 Mr. 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 (214) 253-5251. 
  
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director