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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Regancrest Holsteins, Inc.7/2/10

 

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

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100

July 2, 2010


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


WARNING LETTER
Ref: KAN 2010-05


Francis C. Regan, President
Regancrest Holsteins, Inc.
1095 Highway 9
Waukon, Iowa 52172-7744


Dear Mr. Regan:

On March 8 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1095 Highway 9, Waukon, Iowa. 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 the FDA's web page at www.fda.gov.


We found that you adulterated the new animal drugs DiMethox (Sulfadimethoxine 12.5% Solution Oral Form, ANADA 200-030), Agrimycin 100 (Oxytetracycline Hydrochloride Injection, ANADA 200-452), and TyloVed (Tylosin Phosphate 200 mg/mL Injection, NADA 138-955). Specifically, our investigation revealed that you did not use DiMethox, Agrimycin 100, and TyloVed as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. Title 21, Code of Federal Regulations (C.F.R.), 530.3(a) (21 C.F.R. 530.3(a)).


The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 sulfadimethoxine to a lactating dairy cow without following the route of administration and the conditions of use as stated in the approved labeling. Stilfafimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41 (a)(9). Our investigation also found that you administered oxytetracycline to a lactating dairy cow without following the conditions of use as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a license veterinarian, in violation of 21 C.F.R. 530.11 (a). Furthermore, our investigation found that you administered tylosin to a lactating dairy cow without following the route of administration as stated in the approved labeling. Your extralabel use of tylosin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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.


You should notify this office in writing of the step 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, 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 Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about this letter, please contact Compliance Officer Amy E. Devine at 913-752-2719.


Sincerely,
/S/

John W. Thorsky
District Director
Kansas City District