Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm401289.htm
Timestamp: 2019-04-25 16:35:59+00:00

Document:
On March 12, 17, 25, and 31, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 29130 Road 56, Visalia, 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 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 October 31, 2013, you sold a heifer (ear tagged # (b)(4)), for slaughter as food to (b)(4). On October 31, 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 desfuroylceftiofur at 2.24 parts per million (ppm) in the kidney tissue and flunixin at 0.2 ppm in the liver tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur (marker residue for ceftiofur) in the uncooked kidney tissues 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 uncooked liver tissues of cattleas codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissue from this animal 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).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs flunixin meglumine ((b)(4)), penicillin G procaine ((b)(4)), oxytetracycline hydrochloride ((b)(4)), and tylosin ((b)(4)). Specifically, our investigation revealed that you did not use flunixin meglumine, penicillin G procaine, oxytetracycline hydrochloride, and tylosin as directed by their approved labeling and/or your servicing veterinarian’s 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.
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered flunixin meglumine to your heifer, identified with ear tag #(b)(4) and your lactating dairy cows, without following the dosage, route of administration, and indications for use as stated in your servicing veterinarian’s prescription. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a) and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
Our investigation found that you administered penicillin G procaine to your lactating dairy cows without following the dosage, dosage per injection site, indications for use, and duration of the treatment as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
Our investigation also found that you administered oxytetracycline hydrochloride to your lactating dairy cows without following the route of administration, indications for use, and class of animal as stated in the approved labeling. Your extralabel use of oxytetracycline hydrochloride was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
Our investigation also found that you administered tylosin to your lactating dairy cows without following the class of animal and dosage per injection site as stated in the approved labeling. Your extralabel use of tylosin was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
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).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Your written response should be sent to Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.

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