Aurobindo Pharma Limited

CLOSEOUT LETTER Aurobindo Pharma Limited MARCS-CMS 577033 — February 09, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3004611182 Product: Drugs Recipient: Recipient Name Mr. K. Nithyananda Reddy Recipient Title Managing Director Aurobindo Pharma Limited Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal) Srikakulam District 532409 Andhra Pradesh India Issuing Office: Center for Drug Evaluation and Research | CDER 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 320-19-27 dated June 20, 2019. Based on our evaluation, it appears that you have addressed the 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Tamara Rosbury, Ph.D. Compliance Officer Division of Drug Quality II Content current as of: 02/10/2023 Regulated Product(s) Drugs