Public Health Service
Food and Drug Administration
Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
January 13, 2015
RETURN RECEIPT REQUESTED
/or/ United Parcel Service
Mark A. Schouten, Owner
Sunny Boys Dairy
1360 South 2500 East
Delta, Utah 84624-7403
Dear Mr. Schouten:
On November 3-5, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1360 S 2500 E, Delta, Utah 84624-7403. 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 dairy 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) (sterile Penicillin G Procaine, injectable suspension, (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 21 C.F.R. 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 (b)(4) § 360b(a)], and adulterated within the meaning of section 501(a)(5) of the FD&C Act,[21 U.S.C. § 351(a)(5)]. (sterile Penicillin G Procaine, injectable suspension, (b)(4)) to your culled dairy cow, back tag (b)(4), without following the recommended dose and route of administration and for treating a condition (Mastitis) not identified in the approved product 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. § 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 Matthew R. Dionne, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Dr. Dionne at (303) 236-3064 or e-mail at firstname.lastname@example.org.