Henan Lihua Pharmaceutical Co., Ltd.

CLOSEOUT LETTER Henan Lihua Pharmaceutical Co., Ltd. MARCS-CMS 548089 — August 12, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3001164052 Product: Drugs Recipient: Recipient Name Mr. Nui Zhigang Recipient Title General Manager Henan Lihua Pharmaceutical Co., Ltd. Middle of Huanghe Street Anyang Shi Henan Sheng , 455000 China Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Zhigang: The food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-18-58 dated June 12, 2018. Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Kevin Maguire Compliance Officer Division of Drug Quality II Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research, FDA Content current as of: 08/23/2021 Regulated Product(s) Drugs