Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cowles-farms-llc-448882-01302015
Timestamp: 2019-07-21 01:09:01
Document Index: 417073994

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

Cowles Farms, LLC - 448882 - 01/30/2015 | FDA
Cowles Farms, LLC - 448882 - 01/30/2015
Cowles Farms, LLC MARCS-CMS 448882 — Jan 30, 2015
Mr. Thurlow Y. Cowles
Cowles Farms, LLC
1818 Oak Hill Rd.
Marietta, NY 13110-9738
WARNING LETTER NYK-2015-22
Mr. Thurlow Y. Cowles, Co-Owner
Mr. Jonathan Cowles, Co-Owner
Marietta, New York 13110-9738
Dear Messers Cowles:
On December 5 and 11, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1818 Oak Hill Road, Marietta, New York. 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 10, 2014, you sold a bob veal calf identified with back tag (b)(4) for slaughter as food. On or about June 12, 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 1.48 parts per million (ppm) in the kidney and the presence of flunixin 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)). Additionally, in accordance with 21 C.F. R. 522.970, flunixin is not permitted for use in calves to be processed for veal. Therefore, the presence of these drugs in edible tissues from this animal 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 (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).
Our investigation found that you administered (b)(4) to a bob veal calf with ear tag (b)(4) without following the dosage as stated in the approved label. Also, our investigation found that you administered (b)(4) to a class of animal, veal calves, not set forth in the approved labeling. Our investigation also found that you administered (b)(4) to a bob veal calf with ear tag (b)(4), a class of animal not set forth 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). Your extralabel use of ( b4 ) resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c). Your extralabel use of a cephalosporin (b)(4) at an unapproved dosage, 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. § 360(b)(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
In addition, you adulterated (b)(4) (containing lasalocid) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.