Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394685.htm
Timestamp: 2019-04-22 10:03:43+00:00

Document:
On January 8, 13, and 15, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 7015 Crooked Brook Road, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection 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 a bob veal calf 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 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 3, 2013, you sold a bob veal calf, subsequently identified with sale tag (b)(4) and NYS tag (b)(4) for slaughter as food. On or about June 4, 2013 (b)(4) (USDA Establishment No. (b)(4)) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) collected tissue samples from this animal on June 4, 2013 which identified the presence of sulfamethazine at a level of 64.87 part per million (ppm) in uncooked liver tissue and 40.70 ppm in uncooked muscle tissue of the animal. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.). Section 556.670 (21 C.F.R. 556.670). However, this tolerance does not apply to use of (b)(4) Antibacterial Sulfamethazine Sustained Release Calf Bolus (NADA (b)(4)) in bob veal calves (pre-ruminating calves). There is no acceptable level of residue associated with the use of this drug in veal calves. The presence of this drug in uncooked edible tissue from this animal 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).
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 treatment records for the animals you medicated in order to control the administration of drug treatments to your animals. Food from animals 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 (b)(4) Antibacterial Sulfamethazine Sustained Release Calf Bolus (NADA (b)(4)), Sterile Penicillin G Procaine Injectable Suspension U.S.P. (NADA (b)(4)), and (b)(4) Penicillin G Procaine in Sesame Oil (NADA (b)(4)). Specifically, our investigation revealed you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under 21 C.F.R. 530.3(a).
Our investigation found that you administered (b)(4) Antibacterial Sulfamethazine Sustained Release Calf Bolus (NADA (b)(4)) to your bob veal calf subsequently identified with sale tag (b)(4) and NYS tag (b)(4) without following the animal class as stated on the approved labeling. Your extralabel use of (b)(4) Antibacterial Sulfamethazine Sustained Release Calf Bolus (NADA (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 resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug is not in conformance with its approved labeling and did not comply with 21 C.F.R. 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 also found that you administered Penicillin Sterile PenicillinG Procaine Injectable Suspension U.S.P. (NADA (b)(4)) to treat livestock diagnosed with infections of the uterus without following the approved labeling. You administer 20cc in the muscle using multiple injections in the same injection site, in excess of the approved labeling. Your extralabel use of Sterile Penicillin G Procaine Injectable Suspension U.S.P. ((NADA (b)(4)) was not under the supervision of a licensed veterinarian. Because your use of this drug is not in conformance with its approved labeling and did not comply with 21 C.F.R. 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).
In addition, our investigation found that you administer (b)(4) Penicillin G Procaine in Sesame Oil (NADA (b)(4)) to your dairy cows, and the drug subsequently goes into your cow's colostrum. You allow your bob veal calves access to these treated dairy cows without following the instructions to "discard all milk for 72 hours (6 milkings) following calving or later" as stated in the approved labeling. Your practice is to sell these bull calves for slaughter within days of their birth. Your extralabel use of (b)(4) Penicillin G Procaine in Sesame Oil (NADA (b)(4)) is in or on feed, in violation of 21 C.F.R. 530.11(b). Because your use of this drug is not in conformance with the approved labeling and does not comply with 21 C.F.R. 530, you cause 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).
In addition, you adulterate your dairy cow's medicated colostrum within the meaning of section 501 (a)(6) of the FD&C Act, 21 U.S.C.§ 351 (a)(6), when you allowed your bob veal calves to ingest this medicated feed. The feeding of this medicated feed (colostrum) without following its prohibited use as directed by the approved labeling of (b)(4) Penicillin G Procaine in Sesame Oil (NADA (b)(4)) causes this medicated feed to be unsafe under section 512 of the FD&C Act [21 U.S.C.§ 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.
Your written response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark by phone at (716) 846-6236 or email at patricia.clark@fda.hhs.gov.

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