Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vl-furtado-dairy-04072015
Timestamp: 2019-08-17 17:11:55
Document Index: 597806168

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

VL Furtado Dairy - 04/07/2015 | FDA
VL Furtado Dairy - 04/07/2015
VL Furtado Dairy Apr 07, 2015
VL Furtado Dairy
CMS: 453372
Victor C. Furtado, Co-Owner
Linda M. Furtado, Co-owner
3061 Clubhouse Court
Hanford, California 93230-9453
Dear Mr. and Mrs. Furtado:
On February 10 and 12, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3855 7th Avenue, Hanford, California. 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 three animals for slaughter as food that were 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 November 6, 2014, you sold a dairy cow identified with back tag (b)(4) for slaughter as food. On or about November 6, 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 2.15 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur)in the kidney and 1.28 ppm of flunixin in the liver. Our investigation also revealed that on or about December 15, 2014, you sold a dairy cow identified with back tag (b)(4) for slaughter as food. On or about December 15, 2014, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 1.88 ppm of desfuroylceftiofur in the kidney and 5.37 ppm of flunixin in the liver. Our investigation also revealed that on or about December 22, 2014, you sold a dairy cow identified with back tag (b)(4) for slaughter as food. On or about December 22, 2014, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.49 ppm of desfuroylceftiofur in the kidney and 0.602 ppm of penicillin in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113). Also, FDA has established a tolerance of 0.125 ppm of flunixin in the liver tissue of cattle as codified in 21 C.F.R. 556.286. Also, 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. 556.510.The presence of these drugs in edible tissues from these animals in these amounts 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).
We also found that you adulterated the new animal drugs (b)(4) (flunixin meglumine, NADA (b)(4)), (b)(4) (penicillin G procaine, NADA (b)(4)), (b)(4) (isoflupredone acetate, NADA (b)(4)), and (b)(4) (oxytetracycline, NADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) 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). We have enclosed a copy for your reference.
Our investigation also found that you administered (b)(4) to your dairy cows without following the dosage as stated in the approved label. Also, our investigation found that you administered (b)(4) to your dairy cows without following the dosage or dosage per injection site as stated in the approved label. Our investigation also found that you administered (b)(4) without following the route of administration as stated in the approved label. Our investigation also found that you administered (b)(4) without following the route of administration or duration as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling, you caused the 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).