Inspections, Compliance, Enforcement, and Criminal Investigations
Dean and Jean Mikalunas 7/31/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, New York 11433
July 31, 2014
WARNING LETTER NYK 2014-50
VIA UNITED PARCEL SERVICE
RETURN RECEIPT REQUESTED
Dean F. Mikalunas, Owner
Dean and Jean Mikalunas Farm
7572 State Highway 12
Sherburne, New York 13460-2607
Dear Mr. Mikalunas:
On April 9 and 21, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7572 State Highway 12, Sherburne, New York 13460-2607. 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 adulterated the new animal drug (b)(4) (ceftiofur sodium sterile powder), ANADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling or by a servicing veterinarian's prescription. 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)). We have enclosed a copy for your reference.
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 (b)(4) (ceftiofur sodium sterile powder, ANADA (b)(4)) to your dairy cows without following the recommended withdrawal time (four days) from slaughter as stated on the approved labeling. Your extralabel use of (b)(4) 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.
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 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.clarkfda.hhs.gov.
Ronald M. Pace
New York District