Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm427438.htm
Timestamp: 2019-04-19 10:52:00+00:00

Document:
On September 15-17, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1350 South 2250 East, Hazelton, Idaho 83335. 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 February 18, 2014, you sold a dairy cow identified with ear tag (b)(4), back tag (b)(4), and retain tag (b)(4) for slaughter as food. On or about February 18, 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 0.17 parts per million (ppm) of ampicillin in the kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40, 21 C.F.R. 556.40. The presence of this drug in edible tissue from this animal in this amount 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 Polyflex (Ampicillin, Injectable Suspension, NADA #055-030), Di-Methox (Sulfadimethoxine Injection 40%, Antibacterial, ANADA #200-038), Tetroxy-LA (Oxytetracycline, Injectable, ANADA #200-117), and Excede (Ceftiofur Crystalline Free Acid, Sterile Suspension, NADA #141-209). Specifically, our investigation revealed that you did not use Polyflex, Di-Methox, Tetroxy-LA, and Excede as directed by their approved label or by the 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.
Our investigation found that you administered Polyflex (Ampicillin, Injectable Suspension, NADA #055-030) to your dairy cow, ear tag (b)(4), back tag (b)(4), and retain tag (b)(4), without following the dose set forth in the approved product labeling. Your extralabel use of Polyflex was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Polyflex resulted in illegal residues, 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).
Our investigation found that you administered Di-Methox (Sulfadimethoxine Injection 40%, Antibacterial, ANADA #200-038), to your lactating dairy cows without following the dose set forth in the approved product labeling. Your extralabel use of Di-Methox was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, sulfonamide drugs, which include sulfadimethoxine, are prohibited by 21 CFR 530.41(a)(9), for extralabel use in lactating dairy cattle.
Our investigation found that you administered Tetroxy-LA (Oxytetracycline, Injectable, ANADA #200-117) to your lactating dairy cows without following the dose and species class (i.e. not for use in lactating dairy animals) as set forth in the approved product labeling. Your extralabel use of Tetroxy-LA was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
Our investigation found that you administered Excede (Ceftiofur Crystalline Free Acid, Sterile Suspension, NADA #141-209) to your lactating dairy cows without following the dose as set forth in the approved product labeling. Your extralabel use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, the use of a cephalosporin, by not following the approved labeled dosage rate, is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(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 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).
Your written response should be sent to Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia A. Pinkerton at (425) 302-0428.

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