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June 3, 2019

 

CMS # 577595

 

WARNING LETTER

 

UPS Overnight

 

 

Mr. Rory G. Stricklin

Mrs. Jamie Stricklin

Wewoka Animal Hospital  

12821 Ns 3650

Wewoka, Oklahoma 74884

 

On the dates of February 12, 2019, February 27, 2019, and March 4, 2019, the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice located at 12821 Ns 3650, Wewoka, Oklahoma. Our investigation revealed that your practice caused the new animal drug, (b)(4) Injectable solution (oxtetracycline and flunixin meglumine, (b)(4)), to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (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), because your practice did not comply with the regulation for  Extra-label Drug Use in Animals, Title 21, Code of Federal Regulations (C.F.R.), Part 530 (21 C.F.R. 530). Your actions resulted in an animal being offered for sale for slaughter as food that was 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). 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 extra-label use of approved veterinary or human drugs in animals is permitted only if it complies with section 512(a)(4) and 512(a)(5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and 360b(a)(5), and 21 C.F.R. Part 530. Our investigation found that your firm prescribed and treated various animals in an extra-label manner with the injectable new animal drug (b)(4) and failed to comply with 21 C.F.R. Part 530. Specifically,

 

1.  You failed to maintain complete records for the extra-label use of the new animal drug (b)(4) (oxtetracycline and flunixin meglumine) in accordance with 21 C.F.R 530.5. Our investigation found that your practice was unable to provide complete documentation for the extra-label use of (b)(4) in a bull owned by (b)(6)(b)(7)(C) and a steer owned by (b)(6)(b)(7)(C) at a higher dosage than the label, and a bull owned by (b)(6)(b)(7)(C) treated for an indication for use which is not labeled. Veterinary records of extra-label uses shall be adequate to provide the following information: the established name of the drug and its active ingredient, the condition treated, the species of treated animal, the dosage administered, the duration of treatment, the number of animals treated, and the withdrawal, withholding or discard times.   However, your firm’s transaction records for these animals only include the drug name, dosage administered, and reason(s) for treatment. 

 

2.  On June 11, 2018, your practice treated in an extra-label manner a 1265 lb. bull owned by (b)(6)(b)(7)(C) with 90 mL of the new animal drug (b)(4) Injectable Solution for the treatment of Strangles as per your patient chart and invoice. The recommended label dosage is (b)(4) mL.

 

On December 10, 2018, your practice treated in an extra-label manner a 200 lb. steer calf owned by (b)(6)(b)(7)(C) with 20 mL of the new animal drug (b)(4) Injectable Solution for the treatment of umbilical abscess as per your patient chart. The recommend label dosage is (b)(4) mL.

 

Your firm’s extra-label use of this drug did not meet the requirements of 21 C.F.R.  530.20(a)(2)(ii), 530.20(a)(2)(iii), and 530.20(a)(2)(iv) which require that you:

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• Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable,
• Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
• 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 extra-label treatment.

Your practice failed to record this information for either above-referenced animal. Therefore, you caused the new animal drug (b)(4) to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and thus 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 licensed veterinarians, you are responsible for complying with the requirements of the FD&C Act, including the extra-label use regulations promulgated under the FD&C Act.  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 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 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.

 

Please submit your response to Chad Whitwell, Compliance Officer, at the address of 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions, please contact Mr. Frazier at (214) 253-5328.

 

 

Sincerely,

/S/                                                            

Edmundo Garcia Jr.

District Director

Program Division Director

Office of Human and Animal Food, WD3

 

 

cc:        

Curtis Smith, DVM

Wewoka Animal Hospital 

12821 Ns 3650

Wewoka, OK 74884

 

FSIS District Office 40

Attn: Dr. Jennifer Beasely-McKean, DM

1100 Commerce Street, Room 516

Dallas, Texas 75242-0598

        

Lori Woznicki, Food and Drug Inspections Branch

Manager Division of Regulatory Services

Texas Department of State Health Services

1100 E. 49^th Street – Mail code 1987

Austin, Texas 78756