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Dear Mr. Baker:

 

On April 29 - 30, and June 24, 2019, the U.S. Food and Drug Administration (FDA) conducted an investigation of your Livestock Auction, located at 102 Buckeye Street SW, Sugarcreek, Ohio.  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 the FDA’s Internet web page at www.fda.gov.

 

Violations:

 

We 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.  In addition, you admitted medicating animals you deal and transport for sale at auction, but you were not able to provide documentation that shows you are notifying buyers that animals are medicated.  You also lack an adequate system to identify and segregate animals that have been medicated.  The inspection also documented that bottles of the ceftiofur containing animal drugs, “(b)(4)” had disposable syringes stored in the bottles.  The syringes appeared to contain medication residues from being used and were dirty.  Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 United States Code (USC) 342(a)(4).

 

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 comply with the law.

 

You should take prompt action to correct the above-referenced violations 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.

 

Additional Information:

 

We also note that you stated you have a verbal agreement to prophylactically medicate all animals that you routinely sell to three dealers. It does not appear that medications you are using were prescribed to you for use at your firm. Please note that the extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with Sections 512(a)(4) and (5) of the FD&C Act, 21 USC 360b(a)(4) and (5), and 21 Code of Federal Regulations 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 should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 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.

 

To date, we have not received a response to the Form FDA 483 issued on June 24, 2019.  

 

Please send your correspondence to Kimberly A. Dutzek, Compliance Officer, Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217 or via email orahafeast5firmresponses@fda.hhs.gov.  Any questions you may have regarding this process should be directed to Mrs. Dutzek at (615) 366-7808.

 

Sincerely,

/S/

Steven B. Barber

Director, Division V

Office of Human and Animal Foods Operations-East