| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
February 9, 2010
WARNING LETTER NYK 2010-07
VIA FEDERAL EXPRESS
Simon J. Lomeo, Owner
156 Clinton Street
Whitesboro, New York 13492-2501
Dear Mr. Lomeo:
On October 8, 20, 21, and 22, 2009 the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 156 Clinton Street, Whitesboro, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act), that we found during our investigation of your operation. You can find the Act and its associated regulations on the internet through links on the FDA's web page at www.fda.gov.
We found that you offered two animals for sale for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the 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 within the meaning of section 512 of the Act, 21 U.S.C. 360b. Further, under Section 402(a)(4) of the 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 December 18, 2008, you sold two dairy cows identified with ear tag (b)(4) and (b)(4) for slaughter. On or about December 19, 2008, (b)(4) slaughtered these two animals. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from the cow bearing ear tag (b)(4) identified the presence of sulfadimethoxine in the liver at 3.63 parts per million (ppm) and in the muscle at 2.15 ppm; sulfamethazine in the liver at 2.89 ppm and in the muscle at 1.64 ppm; and, flunixin in the liver at 0.2197 ppm. In addition, USDA/FSIS analyses of tissue samples collected from the cow bearing ear tag (b)(4) identified the presence of sulfadimethoxine in the liver at 6.71 ppm and in the muscle at 3.91 ppm, and flunixin in the liver at 0.4456 ppm. FDA has established a tolerance for residues of sulfadimethoxine in the uncooked edible tissue of cattle at 0.1 ppm, as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640); for residues of sulfamethazine in the uncooked edible tissue of cattle at 0.1 ppm, as codified in 21 C.F.R. 556.670; and for residues of flunixin in the liver of cattle at 125 parts per billion (0.125 ppm), as codified in 21 C.F.R. 556.286.
The presence of these drugs in tissues from the cows bearing eartags (b)(4) and (b)(4) in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).
Our investigation also found 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 Act, 21 U.S.C. 342(a)(4).
We also found that you adulterated the new animal drugs Albon Boluses (NADA 31-715), Liquarnycin LA-200 Injection (NADA 113-232), Prevail Injectable Solution (ANADA 200-308), Supra Sulfate III Sustained Release Boluses (NADA 120-615), and Pen-Aqueous Injectable Suspension (ANADA 65-010); Specifically, our investigation revealed you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extra-label use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 Albon boluses (sulfadimethoxine) and Supra Sulfate III SR Boluses (sulfamethazine) to cows bearing ear tags (b)(4) and (b)(4) without following the withdrawal periods as stated in the approved labeling. Your extralabel uses of Albon and Supra Sulfate III were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a), and your extralabel use of these drugs resulted in illegal drug residues in violation of 21 C.F.R. 530.11(d).
Our investigation also found that you administered Liquamycin LA-200 Injection (oxytetracycline) to cows bearing eartags (b)(4) and (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Your extralabel use of Liquamycin LA-200 was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
Further, our investigation found that you administered Prevail (flunixinmeglurnine) to cows bearing ear tags (b)(4) and (b)(4) without following the route of administration and withdrawal period as indicated by your veterinarian. This extralabel use of Prevail was not under the supervision of a licensed veterinarian in Violation of 21 C.F.R. 530.11(a), and your extralabel use of Prevail resulted in illegal drug residues in violation of 21 C.F.R. 530.11(d).
In addition, our investigation found that you regularly used the above drugs, as well as Pen-Aqueous Injectable Suspension (ANADA 65-010), and the medicated feed AS700 2+2, without following the approved labeling or the extralabel use directions of your veterinarian. Because your use of these drugs were not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).
Finally, our investigation found that you administered chlortetracycline and sulfamethazine, as contained in the medicated feed AS700 2+2 to cows bearing eartags (b)(4) and (b)(4) without following the Withdrawal period as directed by the approved labeling of the medicated feed. In accordance with section 512(a)(4) of the Act, 21 U.S.C. 360b(a)(4), and 21 C.F.R. 530.11(b) the extralabel use of medicated feed is not permitted. Because this use of the medicated feed containing chlortetracycline and sulfamethazine was not in conformance with the approved labeling of the medicated feed you caused the drugs in the feed to be unsafe under section 512(a)(1) of the Act, 21 U.S.C. 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5). Additionally, when you failed to use the medicated feed AS700 2+2 in conformance with its approved labeling you caused the medicated feed to be unsafe under section 512(a)(2) of the Act,
21 U.S.C. 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the Act, 21 U.S.C. 351(a)(6).
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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
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, 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. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
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