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  5. Neo Vision Co Ltd - 02/20/2018
  1. Warning Letters

CLOSEOUT LETTER

Neo Vision Co Ltd


Recipient:
Neo Vision Co Ltd

United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

FEB 20, 2018

Kyung-Hwa Kim
President
New Vision Co., Ltd.
129-1 Donghwagongdan-Ro, Munmak-Eup
Wonju-Si, Gangwon-Do 220801
Republic of Korea

Dear Mr. Kim:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

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. 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/

CAPT Raquel Peat, PhD, MPH
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health
 

 

Cc:
US Agent
Kelly Kim
Kelly Medical Consulting
27001 La Paz Road, Suite# 314
Mission Viejo, CA 92691