Mountain Vista Dairy 12/21/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
December 21, 2012
In reply refer to Warning Letter SEA 13-08
John M. Ficher, Owner
Mountain Vista Dairy
8680 Sollie Smith Road
Tillamook, Oregon 97141
Dear Mr. Ficher:
On October 15-18, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8680 Sollie Smith Road, Tillamook, Oregon. 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
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. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about May 9, 2012, you sold a dairy cow, identified with back tag #(b)(4) (ear tag #(b)(4) yellow), for slaughter as food. On or about May 10, 2012, (b)(4), located at (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 0.25 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 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).
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 a drug inventory system. In addition, expired veterinary drugs were observed in your supply cabinet, available for use on your livestock. 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 new animal drug Pro-Pen-G® Injection (Penicillin G Procaine Injectable Suspension, NADA #065-505). Specifically, our investigation revealed that you did not use Pro-Pen-G® Injection as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 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 Pro-Pen-G® Injection (Penicillin G Procaine Injectable Suspension, NADA #065-505) to your dairy cow without following the dose and amount per injection site as stated in the approved labeling. Your extralabel use of Pro-Pen-G® Injection was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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 your firm’s written response, received following our inspection. A letter was received by our office on November 5, 2012, addressing the observations made during the inspection we conducted at your firm. Although your letter indicates that your firm has taken steps to address our observations, your response is partially adequate. Your response states that you will be administering penicillin in multiple injection sites; however, your response does not address if you will be administering the dosage specified by the drug’s approved labeling. Your response states that you have implemented new drug treatment records; however, your response did not address how your firm will ensure proper implementation of these records by your employees.
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 Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.
Charles M. Breen
cc: Dr. Brad LeaMaster, State Veterinarian
Oregon State Department of Agriculture
Animal Health and Identification Division
635 Capitol Street NE
Salem, Oregon 97310-2532