Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/batemans-mosida-farms-llc-484677-01122016
Timestamp: 2020-05-26 11:03:57
Document Index: 534205359

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

Bateman's Mosida Farms LLC - 484677 - 01/12/2016 | FDA
Bateman's Mosida Farms LLC - 484677 - 01/12/2016
Bateman's Mosida Farms LLC MARCS-CMS 484677 — January 12, 2016
Dr. Robert L. Harding, Owner
Robert L. Harding, DVM Corporation
2279 East 1400 South
Ref: DEN - 16 - 04 - WL
Dear Dr. Harding:
On September 22 and 25, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice. Our investigation revealed that you caused the new animal drug (b)(4) (ceftiofur hydrochloride, NADA (b)(4)), to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5), because your practice did not comply with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (C.F.R.), Part 530 (21 C.F.R. Part 530). Your actions resulted in an animal being offered for sale for slaughter as food that was 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). 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.
The extra-label use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) and 512(a)(5) of the FD&C Act and 21 C.F.R. Part 530.
Our investigation found that you failed to comply with 21 CFR Part 530 in that you prescribed (b)(4), NADA (b)(4), in an extralabel manner to cattle for difficult calving at (b)(4). Specifically, you prescribed a dose of 25 ml once a day for five days with a withdrawal time of 3 days. Your dose, indication for use, and withdrawal time were not based on the labeled instructions. You provided treatment protocols to (b)(4) which instruct the staff to treat cattle using (b)(4) for difficult calving, an indication for which this drug is not approved. Also, the treatment protocol you provided included a meat withholding time of 3 days; however, according to the labeled requirements, cattle must not be slaughtered for 4 days following the last treatment with (b)(4). Also, in the protocol you provided to (b)(4), you prescribe the administration of 25 ml (b)(4) once daily over a five day period irrespective of the body weight of the cow, whereas the highest dosage described in the package insert is 2 mL per 100 lbs of body weight. In addition, the protocol does not include instructions to divide the injection amounts over multiple sites; however, labeling for (b)(4) states not to inject more than 15 mL per injection site.
Furthermore, you failed to comply with 21 C.F.R. Part 530 in that you prescribed (b)(4), to be used in an extralabel manner without assuring the use of this drug would not result in a violative drug residue. Specifically, your prescribed extralabel use of this drug in food-producing animals did not meet the requirements of 21 C.F.R. 530.20(a)(2)(ii) and (iv), which require that you:
Our investigation also found that your prescription for the extralabel use of (b)(4) resulted in an illegal drug residue in violation of 21 CFR 530.11(d). Ceftiofur hydrochloride is prohibited for extralabel use in food producing animals by 21 C.F.R. 530.41(a)(13)(ii).
Our investigation also found that your prescription for the extra-label use of (b)(4) did not meet the requirements of 21 C.F.R. 530.12(c), which require that you provide labeling information that shall include the following:
Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy.
(b)(4) offered a dairy cow, identified with ear tag (b)(4), for slaughter as food that was subsequently found to contain illegal residues in the edible tissue.
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).
The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian working with animals intended as use for human food, you are responsible for complying with the requirements of the Act, including the extra-label use regulations, including but not limited to ensuring the treatment protocols you distribute are in compliance with the law and applicable approved labeling.
Your written response should be sent to Lauren Skokan Priest, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Ms. Priest at (303) 236-9663 or via email at lauren.skokan@fda.hhs.gov.
Bateman's Mosida Farms LLC - Close Out Letter 3/3/17