Strides Pharma Science Limited

CLOSEOUT LETTER Strides Pharma Science Limited MARCS-CMS 576722 — May 23, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Arun Kumar Recipient Title Executive Chairperson & Managing Director Strides Pharma Science Limited Strides House, Bilekahalli Bannerghatta Road Bangalore 560076 India Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Kumar: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-28 dated July 1, 2019. 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/ Christopher Keating Compliance Officer Division of Drug Quality II Cc: Mr. Dayanand Digamberrao More DayanandD.More@strides.com Content current as of: 05/24/2023 Regulated Product(s) Drugs