Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/david-bridgewater-05162016
Timestamp: 2020-07-04 07:21:44
Document Index: 107785623

Matched Legal Cases: ['§ 342', '§ 342', '§ 522', 'art 530', '§ 360', '§ 351']

David Bridgewater - 05/16/2016 | FDA
David Bridgewater - 05/16/2016
David Bridgewater May 16, 2016
David L. Bridgewater, Owner
David Bridgewater Farm
1136 Mount Olivet Road
(CIN-16-489586-15)
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.
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).
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).
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.
cc: Thomas Veterinary Services
156 Vincent St.