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  1. Warning Letters

WARNING LETTER

James D. Hudson Livestock MARCS-CMS 575607 —

Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
James Darren Hudson
Recipient Title
Owner
James D. Hudson Livestock

110 Hudson Road
Caneyville, KY 42721
United States

Issuing Office:
Office of Human and Animal Food Operations-East V

6751 Steger Drive
Cincinnati, OH 45237
United States

513-679-2700

WARNING LETTER 575607

APRIL 11, 2019

UNITED PARCEL SERVICE

Delivery Signature Requested

                                                                                                     

James Darren Hudson, Owner

James D. Hudson Livestock

110 Hudson Road

Caneyville, Kentucky 42721

 

Dear Mr. Hudson:

On February 5, 13-14, 2019, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle grower operation, located at 110 Hudson Rd., Caneyville, Kentucky, as a follow-up to a residue of ciprofloxacin found in a slaughtered cow. 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 Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov

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. You lack a system to ensure animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records and you lack an adequate system to identify animals that have been medicated. 

The inspection also documented that you reuse syringes that are contaminated with other medications. A bottle of the (b)(4) containing animal drug “(b)(4) injectable solution” observed at your firm was a brown color although is supposed to be (b)(4) liquid. You stated the (b)(4)-containing animal drug “(b)(4) injectable solution” was discolored because you reused a syringe that still contained the (b)(4) containing animal drug “(b)(4).”  You must prevent the drugs in use at your firm from contamination. Furthermore, maintain syringes you use to administer injectable solutions in a well-cleaned stated through appropriate cleaning and sanitation procedures.

We also found expired drugs in your drug storage. For example: (b)(4) containing animal drug, "(b)(4)," expired January of 2015; (b)(4) containing animal drug, “(b)(4),” expired September of 2018; (b)(4), expired August of 2017; (b)(4) containing animal drug, "(b)(4)" expired March of 2016.

Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (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 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 Zada L. Giles, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Dr., Suite 500, Nashville, TN 37217. If you have any questions about this letter, please contact Compliance Officer Zada L. Giles at 615-366-7985 or Zada.Giles@fda.hhs.gov

 

Sincerely,

/S/ 

Steven B. Barber

Director, Division V

Office of Human and Animal Food Operations-East

 

 

cc:    Stephen D. Hampton, DVM/Owner

         Heritage Animal Hospital

         495 S. Main Street

         Morgantown, Kentucky 42261

 

         Robert Stout, DVM

         State Veterinarian

         Kentucky Department of Agriculture

         109 Corporate Drive

         Frankfort, Kentucky 40601