Kumar Organic Products Limited

CLOSEOUT LETTER Kumar Organic Products Limited MARCS-CMS 598683 — July 24, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3009167769 Product: Drugs Recipient: Recipient Name Mr. K. K. Singh Recipient Title Chairman Kumar Organic Products Limited Plot No. 379 Canal Road Maitri Marg, Village Luna, Taluka Padra District Vadodara 391440 Gujarat India Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Singh: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-34 dated April 23, 2020. 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 and/or deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Michael Klapal Compliance Officer Division of Drug Quality II Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 07/27/2023 Regulated Product(s) Drugs