Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lussier-dairy-inc-01262015
Timestamp: 2020-03-28 21:52:07
Document Index: 317911174

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

Lussier Dairy, Inc. - 01/26/2015 | FDA
Lussier Dairy, Inc. - 01/26/2015
Lussier Dairy, Inc. January 26, 2015
Lussier Dairy, Inc.
FLA-15-11
Mr. Matthew S. Lussier, Vice President, Secretary and Treasurer
Mrs. Linda Lussier, President
Hawthorne, Florida 32640-3418
Dear Mr. and Mrs. Lussier:
On December 3, 4 and 5, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 4203 SE US Highway 301 Hawthorne, 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 June 23, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food. On or about June 27, 2014, (b)(4), Florida 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 8.16 parts per million (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)).
Our investigation also revealed that on or about July 14, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food. On or about July 17, 2014, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of penicillin at 0.239 ppm in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 C.F.R., Section 556.510 (21 C.F.R. 556.510). The presence of these drugs 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 Bactracillin G (Penicilllin G Procaine, NADA 065-010) and Excede (Ceftiofur Crystalline Free Acid, NADA-141-209). Specifically, our investigation revealed that you did not use Bactracillin G and Excede 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 Bactracillin G to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indications for use and dosage as stated in the approved label. Our investigation also found that you administered Excede to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indications for use and route of administration as stated in the approved label. Your extralabel use of Bactracillin G and Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of Bactracillin and Excede resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of a cephalosporin (Excede), by an unapproved route of administration, 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).
We note your response via email received on December 16, 2014 with a hard copy received in our office on December 30, 2014. All voluntary corrections indicated in your response will be verified at the next scheduled inspection of your farm.
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.