GPT Pharmaceuticals Private Ltd

CLOSEOUT LETTER GPT Pharmaceuticals Private Ltd MARCS-CMS 590938 — June 02, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3008311641 Product: Drugs Recipient: Recipient Name Mr. Ashok Adityan Recipient Title Managing Director GPT Pharmaceuticals Private Ltd 11-1, C.I.E.E, Grandhinagar Balanagar Hyderabad 500037 India Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Adityan: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-13 dated December 17, 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/ Lynnsey Renn, Ph.D. Compliance Officer Division of Drug Quality II Content current as of: 06/06/2023 Regulated Product(s) Drugs