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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Lester Troyer Farm 10/25/11

  

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) 679-2761

 

                                                                                                                                                                              
WARNING LETTER
CIN-12-216255-04
 
 
Via United Parcel Service
 
October 25, 2011     
 
Mr. Lester E. Troyer, Owner
Lester Troyer Farms
699 South Swinehart Road
Apple Creek, Ohio 44606
 
Dear Mr. Troyer:
 
On July 26 and 27, and August 1, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 699 South Swinehart Road, Apple Creek, Ohio. 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 February 24, 2011, you sold a bob veal calf, identified with back tag (b)(4) for slaughter as food. On or about February 25, 2011, (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 sulfamethoxazole at 1.063 parts per million (ppm) in the muscle tissue and at 0.624 ppm in the liver tissue. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of cattle. The presence of this drug in edible tissues from this animal in these amounts 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 treatment records. 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 human drugs sulfamethoxazole and trimethoprim. Specifically, our investigation revealed that you did not use the sulfamethoxazole and trimethoprim product as directed by its approved labeling and your veterinarian’s prescribed labeling. Use of these drugs in this manner is an extralabel use, Title 21, Code of Federal Regulations, Part 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 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 sulfamethoxazole and trimethoprim to a bob veal calf without following the withdrawal period as stated in your servicing veterinarian’s prescribed labeling. Your extralabel use of sulfamethoxazole and trimethoprim was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with your servicing veterinarian’s prescribed 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.
 
Our investigation also revealed that on or about December 9, 2010, you provided (b)(4) with a signed Livestock Owner Certificate stating that you were not marketing livestock at (b)(4) Inc. with an illegal level of drug residues. This signed Livestock Owner Certificate covered the bob veal calf identified with back tag (b)(4) which was found to have a violative sulfamethoxazole residue. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h).  You should take appropriate actions to ensure that this violation does not recur.
 
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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 Extension 2134.
 
 
Sincerely yours,
/S/
Jane M. Kreis
Acting District Director
Cincinnati District
 
 
cc:   
 
Dr. Tony Forshey, Acting Chief (redacted copy)
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, Ohio 43068-3399
 
Ken Blanchard, D.V.M.
Gary Topp, D.V.M.
Dennis Trautwein, D.V.M.
Nathan Steiner, D.V.M.
Craig Zimmerly, D.V.M.
Country Road Veterinary Services LLC
6732 Dover Road
Apple Creek, Ohio 44606