Inspections, Compliance, Enforcement, and Criminal Investigations
James W. Michalek 11/26/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York DistrictJamaica, NY 11433
158-15 Liberty Avenue
November 26, 2013
WARNING LETTER NYK-2014-10
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. James W. Michalek, Co-Owner
Mrs. Sandra D. Michalek, Co-Owner
1068 Clinton Street Road
Attica, New York 14011
Dear Mr. and Mrs. Michalek:
During September 18 through September 26, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1068 Clinton Street Road, Attica, 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 within the meaning of 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 March 28, 2013, you sold a bob veal calf, identified with ear tag (b)(4), for slaughter as food. On or about March 29, 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 and flunixin meglumine in the kidney tissue. FDA has not established a tolerance for residues of tulathromycin and flunixin meglumine in the edible tissues of calves intended for slaughter for veal. The presence of these drugs in edible tissue from this animal 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 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 drugs (b)(4) (Tulathromycin) Injection, (b)(4) and (b)(4) (Flunixin Meglumine) Injection, (b)(4). Specifically, our investigation revealed that you did not use tulathromycin and flunixin meglumine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under 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 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 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 tulathromycin and flunixin meglumine to a bob veal calf, identified with ear tag (b)(4), without following the animal class and withdrawal period as stated in the approved labeling. Your extralabel use of tulathromycin and flunixin meglumine was 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 an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs to be unsafe within the meaning of 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 are 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 LCDR Frank Verni, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact LCDR Frank Verni, Compliance Officer at (718) 662-5702 or by email at firstname.lastname@example.org.
Ronald M. Pace
New York District