Cosmax USA, Inc.

CLOSEOUT LETTER Cosmax USA, Inc. MARCS-CMS 606909 — March 01, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: 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. Sincerely, /S/ Nicholas F. Lyons Director of Compliance Division of Pharmaceutical Quality Operations III Content current as of: 03/13/2023 Regulated Product(s) Drugs