Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/todd-patty-meech-dairy-farm-07102014
Timestamp: 2020-08-10 03:56:03
Document Index: 366552529

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

Todd & Patty Meech Dairy Farm - 07/10/2014 | FDA
Todd & Patty Meech Dairy Farm - 07/10/2014
Todd & Patty Meech Dairy Farm July 10, 2014
Refer to MIN 14 – 21
Todd R. Meech, Co-owner
Patty Meech, Co-owner
24615 County Road 12
Sebeka, Minnesota 56477-2366
Dear Mr. and Mrs. Meech:
On May 28 and 29, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 24615 County Road 12, Sebeka, Minnesota. This letter notifies you of 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 October 21, 2013, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about October 23, 2013, (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 sulfadimethoxine at 0.366 parts per million (ppm) in the liver and 0.377 ppm in the muscle. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.640 (21 CFR 556.640). The presence of this drug 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 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 complete treatment records and failed to maintain records regarding the identity of an animal that you transported and delivered for sale at an auction yard. Food from an animal 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 new animal drug (b)(4) (sulfadimethoxine) Boluses, NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) (sulfadimethoxine) Boluses, NADA (b)(4), as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined under 21 CFR 530.3(a). A copy is attached for your reference.
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 FD&C 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 (b)(4) (sulfadimethoxine) Boluses, NADA (b)(4), to your dairy cow identified with back tag (b)(4) and ear tag (b)(4) without following the dosage as stated in the approved label. Your extralabel use of the drug was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Furthermore, sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 CFR 530.41(a)(9). 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).
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.