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CLOSEOUT LETTER

WalkMed, LLC 01/05/2017

WalkMed, LLC - Close Out Letter 5/1/17


WalkMed, LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
Denver District Office
6th Ave and Kipling Street, P.O. Box 25087
Denver Federal Center, Bldg 20
Denver, CO 80225 

May 1, 2017

Certified Mail
Return Receipt Requested
/or/ United Parcel Service

Mr. Ross Kurz, President
WalkMed Infusion, LLC
6555 South Kenton Street, Suite 304
Centennial, CO 80111

Dear Mr. Kurz:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-01 WL, dated November 2, 2015. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter pertaining to your Triton and Triton FP infusion pumps and associated tubing sets. We acknowledge receipt of your written response dated March 7, 2017 which states that WalkMed Infusion has sold the Triton Infusion pump 510(k) to a new firm who will be responsible for the products going forward. Your written commitments also state that WalkMed Infusion will no longer be manufacturing any medical devices or engaged in activities under the purview of the FDA Future FDA inspections and regulatory activities will further verify your written commitments.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority should your firm elect to restart operations. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,

/S/

LaTonya M. Mitchell
District Director
Denver District