Public Health Service Food and Drug Administration
900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390
RETURN RECEIPT REQUESTED
July 22, 2014
Mr. James R. Hoke
197 Hoke Road
Mount Pleasant, Pennsylvania 15666
Dear Mr. Hoke:
On May 7, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 197 Hoke Road, Mount Pleasant, Pennsylvania. 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.
Our investigation found that you adulterated the new animal drug Combi-Pen-48 (penicillin G benzathine and penicillin G procaine, NADA 065-506). Specifically, our investigation revealed that you did not use Combi-Pen-48 as directed by its approved labeling or veterinarian prescription label. 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)).
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 Combi-Pen-48 to a dairy cow, identified with metal ear tag (b)(4), and plastic ear tag (b)(4), without following the withdrawal period as stated on the veterinarian prescription label. Your extra label use Combi-Pen-48 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 the approved label directions 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 Yvette Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Johnson at (215) 717-3077 or e-mail at Yvette.Johnson @fda.hhs.gov.