WARNING LETTER
Shriver III, Victor L., a.k.a. Chip MARCS-CMS 513435 —
- Product:
- Animal & Veterinary
- Recipient:
- Shriver III, Victor L., a.k.a. Chip
United States
- Issuing Office:
- Chicago District Office
United States
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Chicago District Office
550 W. Jackson Blvd., 15th Floor Chicago, IL 60661 Telephone: (312) 363-6863 Fax: (312) 596-4187 |
April 28, 2017
WARNING LETTER
CHI-8-17
VIA UPS NEXT DAY
SIGNATURE REQUIRED
CORRECTED COPY
Victor L. Shriver, III, a.k.a. Chip Shriver, Managing Partner
Daniel H. Shriver, Partner
Jonathan W. Shriver, Partner
2003 Highway 96 North
Ursa, Illinois 62376
Dear Messrs. Shriver:
On October 17, 2016 and October 28, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2003 Highway 96 North, Ursa, Illinois. 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 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 (b)(4) animal drug (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 under Title 21, Code of Federal Regulations (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) to (b)(4) dairy cows identified with ear tags (b)(4) without following the indications for use and dosage, as stated in the approved labeling. Your extralabel use of (b)(4) is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(9). 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(s) 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.
We acknowledge receipt of your November 9, 2016 response to the FDA Form 483 issued to your firm on October 28, 2016. Although your letter indicates that your firm has taken steps to address our observations, your response did not contain enough detail for us to evaluate. The corrections your firm has implemented will be evaluated and verified during a future inspection.
Please notify this office in writing within fifteen (15) business days of receiving this letter, the steps you have taken to bring your firm into compliance with the law. 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 addressed to:
Lauren Crivellone, Compliance Officer
FDA Chicago District Office
U.S. Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Refer to the Unique Identification Number (CMS# 513435) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone via email at lauren.crivellone@fda.hhs.gov or by phone at (312)-596-4157.
Sincerely,
/S/
William Weissinger
District Director
Chicago District
e-copy:
Chuck Crawley, Bureau Chief
Illinois Department of Agriculture
Paul Wolseley, District Manager
United States Department of Agriculture
Food Safety and Inspection Service