Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC

CLOSEOUT LETTER Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC MARCS-CMS 654751 — May 19, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: 2851, CMS 654751 Product: Drugs Recipient: Recipient Name Kunjal Joshi Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC 2004 Orville Drive North Ronkonkoma , NY 11779 United States kunjal@prodosepharma.com kunjal@spiritpharma.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Kunjal Joshi: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2851, CMS 654751. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA 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/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Content current as of: 05/22/2025 Regulated Product(s) Drugs