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CLOSEOUT LETTER

Infopia Co., Ltd.


Infopia Co., Ltd.

  

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

Public Health Service
 Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center- W066-G609
Silver Spring, MD 20993-0002

SEP 14 2015
 

Mr. Andrew Koh, CEO
lnfopia Co., Ltd.
132 Anyangcheondong-ro Dongan-Gu
Anyang-si, Gyeinggi-do, KR

Dear Mr. Koh:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS #432756] dated July 10, 2014. We acknowledge your firm is still addressing ongoing corrections to 21CFR 820 deviations addressed in this Warning Letter, for which we provided feedback in a letter dated December 14, 2014. Future FDA inspections and regulatory activities will assess the adequacy and sustainability of these ongoing 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/

James L. Woods
Deputy Director Patient Safety
And Product Quality
Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and
Radiological Health