Stason Pharmaceuticals, Inc.

CLOSEOUT LETTER Stason Pharmaceuticals, Inc. MARCS-CMS 604889 — June 24, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Harry T. Fan Recipient Title Chief Executive Officer Stason Pharmaceuticals, Inc. 11 Morgan Irvine , CA 92618 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States 949-608-2900 Dear Mr. Fan: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #604889 and dated July 8, 2020]. 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 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/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 07/07/2021 Regulated Product(s) Drugs