Natuzen Co., Ltd.

CLOSEOUT LETTER Natuzen Co., Ltd. MARCS-CMS 677942 — March 03, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3006731547 Product: Drugs Recipient: Recipient Name Mr. Young-Gi Son Recipient Title President Natuzen Co., Ltd. 289 Namdongdong-Ro Namdong-gu Incheon 21639 South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Son: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-36 dated May 3, 2024. 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 FDA 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/ Joel Hustedt Compliance Officer Division of Drug Quality II Content current as of: 03/11/2025 Regulated Product(s) Drugs