Goran Pharma Pvt Ltd

CLOSEOUT LETTER Goran Pharma Pvt Ltd MARCS-CMS 545331 — March 03, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 3009336980 Recipient: Recipient Name Mr. Hemant D. Dholakia Recipient Title Managing Director Goran Pharma Pvt Ltd GDIC-I, Bhavnagar Road Sihor 364240 Gujarat India Issuing Office: Division of Drug Quality II United States Dear Mr. Dholakia: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-18-48 dated April 24, 2018. 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/ Rokhsana Safaai-Jazi Compliance Officer Division of Drug Quality II Content current as of: 08/05/2020