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  5. Mi Gwang Contact Lens Co., Ltd. - Close Out Letter 9/14/15
  1. Warning Letters

CLOSEOUT LETTER

Mi Gwang Contact Lens Co., Ltd.


Mi Gwang Contact Lens Co., Ltd.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

SEP 14 2015
 

Via United Parcel Service

Jong Gu Park
Chairman and CEO
Mi Gwang Contact Lens Co.
694, Hyeopsek-ri, Namcheon-myeon
Gyeongsan-si, Gyeongsanbuk-do, 1234
Republic of Korea

Dear Mr. Jong Gu Park:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #348781 . Based on our evaluation, it appears that you have addressed the violations contained in this Warning 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/

Carl Fischer, Ph.D.
Director
Division of International Compliance
    Operations
Office of Compliance
Center for Devices and Radiological
    Health