Dr. Reddy's Laboratories Limited

CLOSEOUT LETTER Dr. Reddy's Laboratories Limited MARCS-CMS 481160 — August 27, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 3002949085, 3005447965, and 3006549835 Product: Drugs Recipient: Recipient Name Mr. Satish Reddy Recipient Title Chairman Dr. Reddy's Laboratories Limited 8-2-337, Road No. 3 Banjara Hills, Hyderabad 530046 Andhra Pradesh India Issuing Office: Division of Drug Quality I United States Dear Mr. Reddy: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-16-02 dated November 5, 2015. Based on our evaluation, it appears that you have addressed the violations and 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 violations and deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Carrie Ann Plucinski Compliance Officer Division of Drug Quality I Content current as of: 09/01/2020 Regulated Product(s) Drugs