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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bridgewater Dairy LLC. 2/18/14

  

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

 

February 18, 2014
 
VIA UPS
WARNING LETTER
CIN-14-419190-10
 
Leon D. Weaver, V.M.D., Owner
Bridgewater Dairy, L.L.C.
14587 County Road 8.50
Montpelier, Ohio 43543-9337
 
Dear Dr. Weaver:
 
On December 3, 6, and 9, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 14894 County Road 8.50, Montpelier, 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 March 25, 2013, you sold a dairy cow, identifiedwith ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about March 25, 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 5.35 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in edible tissue from this animal in this amount cause 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 your use of drugs in your veterinary practice at your dairy operation revealed that your practice caused the new animal drug Excenel RTU (ceftiofur hydrochloride) Sterile Suspension, NADA 140-890, to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360b(a)(1), 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 regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530. 
 
The extralabel use of approved veterinary or human drugs in animals is permitted only if it 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. Our investigation found that you failed to comply with the requirements of 21 C.F.R. Part 530, in that the new animal drug Excenel RTU (ceftiofur hydrochloride) Sterile Suspension, NADA 140-890, was not used as directed by its approved labeling in your dairy operation. Specifically, your prescribed use of this drug in your food-producing animal did not meet the requirements of 21 C.F.R. 530.20(a)(2)(iv), which require that you:
 
             (iv)    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 extralabel treatment.
 
In addition, we found that you administered Excenel RTU (ceftiofur hydrochloride) Sterile Suspension, NADA 140-890, to your dairy cow, identified with ear tag (b)(4) and back tag (b)(4), and that you sold this animal for slaughter as food without following the withdrawal period as stated in the approved labeling and your prescription for proper use of the drug. Your improper extralabel use of Excenel RTU (ceftiofur hydrochloride) Sterile Suspension, NADA 140-890, 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 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.
 
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 Stephen J. Rabe, 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 Rabe at 513-679-2700, ext. 2163, or stephen.rabe@fda.hhs.gov.
 
 
Sincerely,
/S/
Paul J. Teitell
District Director
Cincinnati District
 
cc:    
Chris Weaver, Operations Manager
Bridgewater Dairy, L.L.C.
14587 County Road 8.50
Montpelier, Ohio 43543-9337
 
Eric W. Weitzel, Dairy Manager
Bridgewater Dairy, L.L.C.
14587 County Road 8.50
Montpelier, Ohio 43543-9337