Keshava Organics Private Ltd.

CLOSEOUT LETTER Keshava Organics Private Ltd. MARCS-CMS 540146 — May 12, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: FEI 3003677831 Product: Drugs Recipient: Recipient Name Mr. Dinkar K. Raut Recipient Title Managing Director Keshava Organics Private Ltd. T-97, 98, 99 & 100 MIDC Boisar Palghar Tarapur 401506 Maharashtra India dkraut@keshavaindia.com Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Raut: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-41 dated March 15, 2018. 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 should deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Christina Alemu-Cruickshank Public Health Analyst Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 05/31/2023 Regulated Product(s) Drugs