Azurity Pharmaceuticals, Inc.

CLOSEOUT LETTER Azurity Pharmaceuticals, Inc. MARCS-CMS 656489 — February 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3003395329 Product: Drugs Recipient: Recipient Name Mr. Ronald Scarboro Recipient Title CEO Azurity Pharmaceuticals, Inc. 900 Ridgefield Drive Raleigh , NC 27609 United States rscarboro@azurity.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Scarboro: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (656489) dated September 20, 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/ Carmelo Rosa, Psy.D. Director, Division of Drug Quality I Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research CC: Ms. Marie Romanow Director of Quality Compliance Azurity Pharmaceuticals, Inc. 8 Cabot Road, Suite 2000 Woburn, MA 01801 marie.romanow@azurity.com Content current as of: 03/03/2026 Regulated Product(s) Drugs