- Cannon Farms, LLC
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
November 17, 2015
In reply refer to Warning Letter SEA 16-02
Seth A. Cannon, Member/Manager
Cannon Farms, LLC
1470 North 750 East
Shelley, Idaho 83274-5011
Dear Mr. Cannon;
On September 2, 4, and 10, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1470 North 750 East, Shelley, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigations 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 an animal 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.
Specifically, our investigations revealed that on or about July 9, 2015, you sold a cow identified with ear tag (b)(4) and back tag (b)(4) for slaughter as food. On or about July 9, 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 penicillin at 0.264 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.510 (21 C.F.R. § 556.510). 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).
We also found that you adulterated the new animal drug PenOne Pro (Penicillin G Procaine Injectable, NADA 065-010). Specifically, our investigation revealed that you did not use PenOne Pro as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined by 21 C.F.R. § 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 FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. 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 PenOne Pro to cow with ear tag (b)(4) and back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of PenOne Pro was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of PenOne Pro resulted in an illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 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 producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
FDA acknowledges the written response we received following our inspection conducted September 2-10, 2015. Although the response states corrective action was taken with the employee responsible for the release of the cow, and a letter was sent to (b)(4), it does not provide any documentation of the new protocol. In addition, the response implies that some of the responsibility will be with the slaughter facility, a firm that is not under your control.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (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 fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame 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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia A. Pinkerton at (425) 302-0428.
Miriam R. Burbach
Debra M. Lawrence, D.V.M.
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707