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  5. Netcos Co., Ltd. - 565521 - 11/30/2018
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CLOSEOUT LETTER

Netcos Co., Ltd. MARCS-CMS 565521 — 30/11/2018

Netcos Co., Ltd. - 565521 - 11/30/2018


Recipient:
Recipient Name
Bae Tae-Jong
Netcos Co., Ltd.
Netcos Co., Ltd.

3/F Seocho-dong 23- 12 Hyoryeong-ro 60-Gil
Seocho-gu
Seoul
06721
South Korea

Issuing Office:

Silver Spring, MD 20993-0002
United States


Dear Bae Tae-Jong:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 1326, issued on October 29, 2018 Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product by the way of including a marketing end date. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions.

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 to 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/
Maria Rossana R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research