WARNING LETTER
Butts Dairy Farm MARCS-CMS 535849 —
- Delivery Method:
- UPS
- Product:
- Animal & Veterinary
- Recipient:
-
Recipient NameCharles K. Butts
- Butts Dairy Farm
553 N County Road 500 W
Cory, IN 47846-8004
United States
- Issuing Office:
- Chicago District Office
United States
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Chicago District Office |
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WARNING LETTER
FY18-HAFE6-03
November 1, 2017
VIA UPS
Charles K. Butts, Owner
Butts Dairy Farm
553 N County Road 500 W
Cory, Indiana 47846-8004
Dear Charles Butts:
On June 19, 2017 and June 21, 2017 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 553 N County Road 500 W, Cory, Indiana. 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. You failed to maintain complete treatment records, failed to maintain an adequate inventory system for animal drugs, and failed to dispose of expired drugs. Specifically, your treatment records do not identify the animal treated, dates of treatment, drug administered, individual who administered the medication, drug dosage, route of administration or recommended withdrawal time for meat and milk. Further, your drug inventory system is inadequate for determining the quantities of drugs used to medicate your livestock. In addition, expired (b)(4), and (b)(4) were found in your drug storage area. 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).
Our investigation also found that you adulterated the new animal drug (b)(4) because you did not use this drug as directed by its approved labeling or veterinary prescription. You stated that you administered (b)(4) to cow #(b)(4) without following the dosage or indication for use as stated in the approved labeling. Specifically, you administered (b)(4) for the treatment of foot rot, whereas the labeled indication is for the treatment of bacterial pneumonia (shipping fever). You also administered dosages of 20, 30 and 40 ml of (b)(4) whereas the labeled dosage is 14 ml [1 ml/100 pounds of body weight]. Use of this drug in this manner is an extralabel use. See 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. You did not consult a veterinarian for your extralabel use.
We received your FDA-483, Inspectional Observations response letter, dated July 5, 2017. We reviewed your response and determined that it was inadequate as you did not provide evidence that corrective actions were taken. For example, you did not provide treatment records, documentation for the disposal of expired drugs, and/or proof for implementation of a drug inventory system.
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 Lauren Crivellone, Compliance Officer, U.S. Food and Drug Administration, 550 W. Jackson Boulevard, Chicago IL 60661. If you have any questions about this letter, please contact Compliance Officer Lauren Crivellone at (312) 596-4157 or by email at Lauren.Crivellone@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Office of Human & Animal Food Operations
Division 6 East
cc:
Bret D. Marsh, DVM, Indiana State Veterinarian
Indiana State Board of Animal Health
Paul Wolseley, District Manager
United States Department of Agriculture
Food Safety and Inspection Service