Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm398305.htm
Timestamp: 2019-04-23 09:56:40+00:00

Document:
On February 11, 2014 through February 13, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 578 Canoe Run, Grayson, 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 the FDA’s web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was 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 June 26, 2013, you sold a cow, identified with back tag (b)(4) for slaughter as food. On or about June 27, 2013, (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 0.55 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney and 0.162 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(b)(3)(i) (21C.F.R. 556.113(b)(3)(i)). FDA has established a tolerance of 0.05 ppm for residues of penicillin in the kidney tissue of cattle as codified in 21, C.F.R. 556.510(a). The presence of these drugs in edible tissue 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 drug Excenel RTU (ceftiofur hydrochloride sterile suspension, NADA140-890). Specifically, our investigation revealed that you did not use Excenel RTU as directed by its approved labeling. 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 Excenel RTU to a dairy cow with Back Tag (b)(4) without following the indications for use and for not adhering to the specified withdrawal time. Your extralabel use of Excenel RTU 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 resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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 Stephen J. Rabe, 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 Rabe at (513)679-2700, ext. 2163, or stephen.rabe@fda.hhs.gov.

References: § 342
 § 360
 § 342
 § 342
 § 360
 § 351