Jason Martindale 10/2/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, New York 11433
October 2, 2013
WARNING LETTER NYK 2014-1
VIA USPS PRIORITY MAIL
Jason A. Martindale, Owner
Riverview Ranch and Livestock
658 River Road
Gansevoort, New York 12831
Dear Mr. Martindale:
On May 30 and June 5 - 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf grower operation located at 658 West River Road, Gansevoort, New York. 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 April 9, 2013 you sold a bob veal calf identified with ear tag No. (b)(4) for slaughter as food. On or about April 10, 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 tulathromycin in the kidney tissue. FDA has not established a tolerance for residues of tulathromycin in the kidney tissue in preruminating calves. The presence of this drug in edible tissues from this animal causes the food to be adulterated within the meaning of section 401(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 treatment records. 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 (b)(4) (tulathromycin) Injectable Solution Antibiotic (NADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling or by your veterinarian. Use of this drug in this manner is an extralabel use. See Title 21 Code of Federal Regulations (C.F.R.) Section 530.3(a) (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 section 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 (b)(4) to a bob veal calf identified with ear tag No. (b)(4) without following the animal class as stated in the approved labeling or as directed by your veterinarian. Your extralabel use of (b)(4) was not under supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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 this 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 from you following our inspection. Your letter dated June 7, 2013 was received on June 27, 2013. While your letter addresses some of the observations made by our investigator, you did not adequately address what actions you may have taken or will take to establish a system to control administration of drug treatments to your animals (FDA 483 Observation 2). You fail to have a written plan with your veterinarian for treating sick calves with approved drugs and proper dosages in order to prevent additional residues.
You should notify this office in writing of the additional 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, stated 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 addressed to: Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-846-6236 or E-Mail at Patricia.Clark@fda.hhs.gov
Ronald M. Pace
New York District