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  5. Neo Vision Co Ltd - 506797 - 02/20/2018
  1. Warning Letters

CLOSEOUT LETTER

Neo Vision Co Ltd MARCS-CMS 506797 —

Recipient:
Recipient Name
Kyung-Hwa Kim
Recipient Title
President
Neo Vision Co Ltd

129-1 Donghwagongdan-Ro
Munmak-Eup
Wonju-si
Gangwon-do
26361
South Korea

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

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

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