Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm467718.htm
Timestamp: 2019-04-23 05:56:16+00:00

Document:
On August 25, 2015 and September 2, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6568 Military Turnpike, Ellenburg Center, 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 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 9, 2015, you sold a bob veal calf, identified with (b)(4), for slaughter as food. On or about June 12, 2015, (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 neomycin at 16.34 parts per million (ppm) in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of IBA Scour Treat 10g, (neomycin sulfate and oxytetracycline hydrochloride) in calves to be processed for veal (pre-ruminant calves), and there is no acceptable level of residue associated with the use of this drug in veal calves. 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).
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 have a system in place to adequately segregate animals, you failed to maintain treatment records and you failed to adequately identify the animals that are transported and delivered for sale at an auction yard. 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 drug IBA Scour Treat 10g (neomycin sulfate and oxytetracycline hydrochloride). Specifically, our investigation revealed that you did not use IBA Scour Treat 10g as directed by the approved labeling. Use of the drug in this manner is an extralabel use. See 21 CFR 530.3(a).
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 Act, 21 U.S.C. § 360b(a)(4) and (5) and 21 CFR 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 IBA Scour Treat 10g to a bob veal calf with (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of IBA Scour Treat 10g was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, your extra-label use of IBA Scour Treat 10g was in or on feed, in violation of 21 C.F.R. 530.11(b) and resulted in and illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 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).
In addition, you adulterated IBA Scour Treat 10g medicated feed 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 extra-label use of medicated feed.
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 are in compliance with the law.
Your written response should be sent to CDR Frank Verni, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact CDR Frank Verni, Compliance Officer at (718) 662-5702 or by email at frank.verni@fda.hhs.gov.

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