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Cosmax USA, Inc. MARCS-CMS 606909 —

Delivery Method:
UPS Next Day

Recipient Name
Mr. Byung-Joo Lee
Recipient Title
Chief Operation Officer
Cosmax USA, Inc.

105 Challenger Road
9th Floor
Ridgefield Park, NJ 07660
United States

Issuing Office:
Division of Pharmaceutical Quality Operations II

United States

Dear Mr. Lee:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [#606909 dated October 15, 2020]. Based on our evaluation, it appears that you have addressed the violation(s) 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.

Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III

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