Hanlim Pharm Co., Ltd.

CLOSEOUT LETTER Hanlim Pharm Co., Ltd. MARCS-CMS 553021 — August 25, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Daniel SC Park Recipient Title Plant Manager Hanlim Pharm Co., Ltd. 2-27, Yeongmun-ro Cheoin-gu Yongin-si Gyeonggi-do 17040 South Korea Issuing Office: Center for Drug Evaluation and Research United States Dear Mr. Park: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-19-01 dated October 3, 2018. 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 or 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/ Rokhsana Safaai-Jazi Compliance Officer Division of Drug Quality II Content current as of: 03/14/2023 Regulated Product(s) Drugs