Hetero Labs Limited Unit V

CLOSEOUT LETTER Hetero Labs Limited Unit V MARCS-CMS 520359 — November 29, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 3008307735 Product: Drugs Recipient: Recipient Name Mr. P. R. Bhaskar Reddy Recipient Title Vice President – Operations Hetero Labs Limited Unit V Surv. No. 439-441, 458 Polepally Village, Jadcherla Mandal Mahaboob Nagar 509301 Telangana 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 320-17-46 dated August 15, 2017. 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/ Jason F. Chancey Consumer Safety Officer Division of Drug Quality I Content current as of: 12/02/2022 Regulated Product(s) Drugs