| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human ServicesApril 29, 2010
WARNING LETTER NYK-2010-13
VIA UPS
Jeffrey T. Maida, Owner
2574 Ira StationRoad
Cato, New York 13033-9505
Dear Mr. Malda:
On March 2 and March 5, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2574 Ira Station Road, Cato, New York 13033-9505. 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 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 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 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 June 16, 2009, you sold a bob veal calf, identified with (b)(4) for slaughter as food. On or about June 17, 2009, (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 florfenicol at 4.40 parts per million (ppm) in the liver and 0.73 ppm in the muscle tissue. FDA has not established a tolerance for residues of florfenicol in the edible tissues of veal calves. The presence of this drug in edible tissue from this animal 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 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 and segregate treated animals. 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 drug florfenicol (b)(4), (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, 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 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 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 florfenicol in a class of animal (veal calf) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of florfenicol resulted in an illegal 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 the drug 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)].
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.
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 Dean R. Rugnetta, 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 Dean Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.
Sincerely yours,
/s/
Ronald M. Pace
District Director
New York District
Enclosure:
21 CFR Part 530
cc: Dr. John P. Huntley, Director
Division of Animal lndustry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235
cc: (b)(4)
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