Inspections, Compliance, Enforcement, and Criminal Investigations

Sudan Vet Services 1/23/15

  

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 

 

January 23, 2015
 
2015-DAL-WL-013
 
WARNING LETTER
 
UPS OVERNIGHT
           
 
Christopher M. Larson, DVM
Sudan Veterinary Services, P.A.
1704 East Highway 84
Sudan, Texas 79371
 
Dear Dr. Larson:
 
On October 31, 2014 and November 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice located at 1704 East Highway 84, Sudan, Texas. Our investigation revealed that your practice caused the new animal drugs (b)(4) (sulfadimethoxine, NADA (b)(4)) and (b)(4) (penicillin G procaine, NADA (b)(4)), to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5), because your practice did not comply with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (C.F.R.), Part 530 (21 C.F.R. Part 530). 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. 
 
The extralabel use of approved veterinary or human drugs in animals is permitted only if it 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. 
 
Our investigation found that you failed to comply with the requirements of 21 C.F.R. Part 530, in that you directed the use of the animal drug (b)(4) in an extralabel manner in a written protocol for your client (b)(4).  You prescribed (b)(4) for metritis, an indication for which it is not labeled, and at a higher dosage than label directions to a (b)(4) dairy cow identified with ear tag (b)(4). Specifically, your prescribed extralabel use of this drug in a food-producing animal did not meet the requirements of 21 C.F.R. 530.20(a)(2)(i), (ii) and (iv), which require that you:
 
(i)    Make a careful diagnosis and evaluation of the conditions for which the drug is to be used;
(ii)    Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable; and
(iii)    Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment.
 
In addition, you used (b)(4) in an extralabel manner by administering the drug to a dairy cow identified with ear tag (b)(4), without following the dose, withdrawal time, and indications for use, as stated in the approved labeling. The extralabel use of this drug in this animal is prohibited by 21 C.F.R. 530.41(a)(9).
 
You caused the aforementioned animal drugs to be unsafe under section 512(a) of the FD&C Act, and adulterated within the meaning of sections 501(a)(5) of the FD&C Act, because the drugs were used in a manner that did not conform with their approved uses or 21 C.F.R. Part 530.
 
The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian, you are responsible for complying with the requirements of the FD&C Act, including the extralabel use regulations promulgated under the FD&C Act. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure 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 enclosed a copy of 21 C.F.R. Part 530 for your reference. We strongly suggest that you review 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the FD&C Act.
 
You should notify this office in writing of the steps you have taken to bring your practice 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, 4040 N. Central Expressway, Suite 300, Dallas, TX 75004. If you have any questions about this letter, please contact Ms. Essary at (214)253-5335.
 
 
Sincerely,
/S/
Reynaldo R. Rodriguez Jr.
Dallas District Director
 
  
cc:       FSIS District Office 40
            Attn: Dr. Jennifer Beasley-McKean, DVM
            1100 Commerce Street, Room 516
            Dallas, TX 75242-0598

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