Inspections, Compliance, Enforcement, and Criminal Investigations
Hardie Farms, Inc. 13-Apr-06
Department of Health and Human Services
Public Health Service
New York District
April 13, 2006
WARNING LETTER NYK 2006-15
RETURN RECEIPT REQUESTED
Stephen J. Palladino, Partner
Hardie Farms, Inc.
31 Holden Road
Lansing, NY 14882
Dear Mr. Palladino:
An investigation of your dairy operation conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 7, and 13, 2005, confirmed that you caused the new animal drug Agri-cillin Procaine Penicillin G to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)]of the Food, Drug and Cosmetic Act (the Act). Specifically, your illegal extra-label use of the drug renders the drug unsafe within the meaning of section 512 [21 U.S.C. 360b] of the Act and, therefore, adulterated under section 501(a)(5). You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.
On or about February 2 through February 7, 2005, you treated a dairy cow bearing ear tag [redacted] and farm tag [redacted] with Agri-cillin Procaine Penicillin G in a manner contrary to its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. 360b(a)(4)] and 512(a)(5) [21 U.S.C. 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extra-label use of Agri-cillin failed to comply with these requirements.
You administered Agri-cillin to a dairy cow without following the daily dosage level, duration of treatment or dosage level per injection site requirements set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug is unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 51(a)(5)] of the Act.
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 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 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 sent to Compliance Officer James M. Kewley at the above address. If you have any questions about this letter, please contact Mr. Kewley at the above address or by phone at (716) 541-0328.
Robert L. Hart
Acting Director, New York District