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  5. David Bridgewater - 05/16/2016
  1. Compliance Actions and Activities

WARNING LETTER

David Bridgewater May 16, 2016

David Bridgewater - 05/16/2016

Product:
Animal & Veterinary

Recipient:
David Bridgewater


United States

Issuing Office:
Cincinnati District Office

United States


   

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

 

May 16, 2016
 
Via United Parcel Service
 
 
David L. Bridgewater, Owner
David Bridgewater Farm
1136 Mount Olivet Road
Bowling Green, KY 42101
 
Warning Letter
(CIN-16-489586-15)
 
 
Dear Mr. Bridgewater:
 
On 12/01/2015 and 12/03/2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock growing and dealing operation located at 1136 Mount Olivet Road, Bowling Green, Kentucky. 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 07/21/2015, you sold a calf, identified with back tag (b)(4), for slaughter as food. On or about 07/22/2015, (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 ciprofloxacin in the kidney tissue. FDA has not established a tolerance for residues of ciprofloxacin, (marker residue for enrofloxacin), in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.226(b)(1). The presence of this drug in edible tissue from this animal 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 identify animals, maintain treatment records of animals or segregate treated animals at your firm. 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 animal drug Baytril 100 (enrofloxacin, NADA 141-068). Specifically, our investigation revealed that you did not use Baytril 100 as directed by its approved labeling or by the servicing veterinarian’s prescription. Use of this drug in this manner is an extralabel use. See 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 Baytril 100 to a calf, identified with back tag (b)(4), without following the withdrawal period and animal class as stated in the approved labeling. Your extralabel use of Baytril 100 was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Baytril 100 is prohibited for extralabel use in calves to be processed for veal by 21 C.F.R. § 522.812(e)(2)(iii) and 530.41(a)(10). 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 Allison M. McGloin, 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 Allison M. McGloin at 513-679-2700 extension 2123 or by e-mail at Allison.McGloin@fda.hhs.gov.
 
 
Sincerely,
/S/
Steven B. Barber
District Director
Cincinnati District
 
 
cc:    Thomas Veterinary Services
         156 Vincent St.
         Smiths Grove, Kentucky 42171