CLOSEOUT LETTER

INCYTO CO., LTD. MARCS-CMS 497916 — October 25, 2018

Product:: Medical Devices

Recipient:: Recipient Name

Shane Cho; Recipient Title

Chief Executive Officer; INCYTO CO., LTD.; 112, Seonggeo-Gil
Seonggeo-Eup
Seobuk-gu
Cheonan-si
Chungcheongnam-do
31044
South Korea

Issuing Office:: Center for Devices and Radiological Health; 10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Mr. Cho:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS#497916] dated September 8, 2016. 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/
Scott Gonzalez
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health

CC (US Agent):

Priscilla Chung
LK Consulting Group USA, Inc.
2651 E Chapman Ave
Ste 110 Fullerton, CA 92831