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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shrock, John E. 03-Sep-08

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

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771


 

WARNING LETTER
(CIN-08-28486-23)

September 3, 2008

Via Federal Express

John E. Shrock, Owner
8852 North Girdle Road
Middlefield, Ohio 44062-9573
 

Dear Mr. Shrock:

On February 20 and 22, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8852 North Girdle Road, Middlefield, Ohio 44062. 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 FDA's web page at www.fda.gov.

Specifically, our investigation revealed that on or about December 3, 2007, you sold a bob veal calf, identified with back tag [redacted] for slaughter as food. On or about December 4, 2007 [redacted] 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 19.94 parts per million (ppm) of sulfamethazine in the liver tissue and 22.94 ppm of sulfamethazine in the muscle tissue of the calf. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.) 556.670 (21 C.F.R. 556.670).

We found that you adulterated the new animal drug sulfamethazine. Specifically, our investigation revealed that you did not use sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 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 suifamethazine to a bob veal calf less than a month old without following the warnings as stated in the approved labeling. Your extralabel use of sulfamethazine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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(s) 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 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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at 513-679-2700 Ext. 162.
 

Sincerely yours,

/s/

Toniette K . Williams
Acting District Director
Cincinnati District
 

cc: Dr Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Suite 300 Landmark Center
1299 Farnam Street
Omaha, NE 68102