Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barrington-dairy-farm-02022015
Timestamp: 2020-02-20 12:44:09
Document Index: 324682055

Matched Legal Cases: ['§ 342', '§ 530', '§ 530', '§ 530', 'art 530', '§ 360', '§ 351', '§ 331']

Barrington Dairy Farm - 02/02/2015 | FDA
Barrington Dairy Farm - 02/02/2015
Barrington Dairy Farm February 02, 2015
FLA-15-12
Mr. Joseph G. Barrington, Owner
20567 168th Street
Live Oak, Florida 32060-5610
On December 3, 4 and 5, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 20567 168th Street, Live Oak, Florida. This letter notifies you of 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 March 15, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food. On or about March 17, 2014, (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 desfuroylceftiofur (marker residue for ceftiofur) at 3.52 parts per million (ppm) in the kidney. Our investigation also revealed that on or about May 27, 2014, you sold a dairy cow identified with back tag (b)(4)(ear tag (b)(4)) for slaughter as food. On or about May 28, 2014, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 3.67 ppm in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney 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 tissues from these animals 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).
We also found that you adulterated the new animal drugs Naxcel (Ceftiofur sodium, NADA 140-338) and Excenel RTU EZ (Ceftiofur hydrochloride, NADA 141-288). Specifically, our investigation revealed that you did not use Naxcel and Excenel RTU EZ as directed by their approved labeling or veterinary prescription. Use of these drugs in this manner is an extralabel use. See 21 § C.F.R. 530.3(a).
Our investigation found that you administered Excenel RTU EZ to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indication for use as stated in the approved label. Also, our investigation found that you administered Naxcel to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the specified route of administration and without following the indication for use as stated in the approved label. Your extralabel use of Excenel RTU EZ and Naxcel was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of Excenel RTU EZ and Naxcel resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of cephalosporin (Excenel RTU EZ and Naxcel), by an unapproved route of administration and at unapproved doses, is prohibited by 21 C.F.R. § 530.41(13)(ii). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs 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).
Our investigation also revealed that on or about March 15, 2014, you signed the (b)(4) buyer/shipper document specifying that the dairy cow identified with back tag (b)(4) was free of illegal amounts of antibiotic residue. On or about March 15, 2014, you delivered a dairy cow identified with back tag (b)(4)(ear tag (b)(4)), which contained violative residues of desfuroylceftiofur, to (b)(4). Our investigation also revealed that on or about May 27, 2014, you signed the (b)(4) buyer/shipper document specifying that the dairy cow identified with back tag (b)(4) was free of illegal amounts of antibiotic residue. On or about May 27, 2014, you delivered a dairy cow identified with back tag (b)(4) (ear tag (b)(4)), which contained violative residues of desfuroylceftiofur, to (b)(4). 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.
Your written response should be sent to Carla Norris, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Carla Norris at (407) 475-4730.