Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm288546.htm
Timestamp: 2017-09-23 07:35:23
Document Index: 147395594

Matched Legal Cases: ['§ 342', '§ 360', 'art 530', 'art 530', '§ 360', '§ 351']

LeCaptain, Mark D. 1/13/12
Mark D. LeCaptain
E2470 LeCaptain Road
Dear Mr. LeCaptain:
On September 22 and 27, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at E2470 LeCaptain Road, Casco, Wisconsin. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 January 26, 2011, you sold a bob veal calf, identified with back tag (b)(4) for slaughter as food. On or about January 28, 2011, (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 tilmicosin in the liver at 13.728 parts per million (ppm) and sulfamethazine in the liver at 10.170 ppm and in the muscle at 8.161 ppm. FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in the liver tissue of cattle, as codified in Title 21, Code of Federal Regulations, section 556.735(b)(1)(i), 21 CFR 556.430(b)(1)(i). However, this tolerance does not apply to the use of (b)(4) (tilmicosin injection), NADA (b)(4) in veal calves (pre- ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) (tilmicosin injection), NADA (b)(4) in veal calves (pre-ruminating calves). FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in 21 CFR 556.670. However, this tolerance does not apply to the use of (b)(4) sulfamethazine), NADA (b)(4) in veal calves (pre-ruminating calves) and there is no acceptable level of residue associated with the use of (b)(4) (sulfamethazine), NADA (b)(4) in veal calves (pre-ruminating calves). Therefore, the presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
We also found that you adulterated the new animal drugs (b)(4) (tilmicosin injection), NADA (b)(4), and (b)(4) (sulfamethazine), NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) (tilmicosin injection), NADA (b)(4), and (b)(4) (sulfamethazine), NADA (b)(4), as directed by their approved labeling and your servicing veterinarian’s written prescription. Use of these drugs in this manner is an extralabel use, 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the 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 the new animal drugs (b)(4) (tilmicosin injection), NADA (b)(4) and (sulfamethazine), NADA (b)(4), to your bob veal calves animal class as stated in the approved labeling or the withdrawal period established by your servicing veterinarian. Your extralabel use of the new animal drugs (b)(4) (tilmicosin injection), NADA (b)(4) and (b)(4) (sulfamethazine), NADA (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and resulted in an illegal residue, in violation of 21 CFR 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and your servicing veterinarian's written prescription and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
Your written response should be sent to Demetria L. Lueneburg, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Compliance Officer Lueneburg at (612) 758-7210.
xc: Steven Ingham, Ph.D.
LeCaptain, Mark D. - Close Out Letter 2/27/12