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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Doughty Valley Holsteins LLC 4/8/14

  

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

 

April 8, 2014                                                  
 
WARNING LETTER                                                                      VIA UPS       
CIN-14-422755-11    
 
Timothy J. Miller, Owner
Doughty Valley Holstein, LLC.
5547 State Route 557
Millersburg, Ohio 44654
 
Dear Mr. Miller:
 
On January 31and February 6 and 11, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5547 State Route 557, Millersburg, Ohio 44654-9488. 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 July 22, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 23, 2013, (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 in the kidney. FDA has not established a tolerance for residues of sulfamethoxazole in calves to be processed for veal. The presence of this drug in edible tissue from this animal in this amount 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 complete 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 new human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, NDC 53746-272-05. Specifically, our investigation revealed that you did not use Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, NDC 53746-272-05, as directed by its approved labeling or by your servicing veterinarian’s prescription. Use of the drug in this manner is an extralabel use as defined under Title 21, Code of Federal Regulations (C.F.R.), Section 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 Double Strength Tablets, USP, NDC 53746-272-05, to a bob veal calf identified with back tag (b)(4) without following the withdrawal period as prescribed by your servicing veterinarian. Your extralabel use of Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, NDC 53746-272-05, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, NDC 53746-272-05, resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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 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).
 
In addition, you adulterated the animal feed that you fed to your calves by adding the human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, NDC 53746-272-05, to the milk and water solution that was fed to your calves, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a)(4), 21 U.S.C. § 360b(a)(4), of the FD&C Act, and 21 C.F.R. Part 530.11(b).  
 
We have received an undated letter from you on February 13, 2014, stating that you have discontinued the use of the sulfamethoxazole and trimethoprim tablets in treating your animals. However, your response does not address if you have taken any corrective actions to ensure that your treatment records are now complete and accurately documented.
 
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 Gina M. Brackett, 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 Gina M. Brackett at (513) 679-2700, ext. 2167or Email at Gina.Brackett@fda.hhs.gov.
 
Sincerely yours,
/S/
Paul J. Teitell
District Director
Cincinnati District