Medgel Private Limited

CLOSEOUT LETTER Medgel Private Limited MARCS-CMS 654085 — May 22, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: FEI 3010165392 Product: Drugs Recipient: Recipient Name Mr. Alok K. Garg Recipient Title Managing Director Medgel Private Limited Plot No. 19-20, Special Economic Zone Pharma Zone, Phase-II, Sector-III Pithampur 454775 Madhya Pradesh India akg@medgel.net Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Garg: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-17 dated July 20, 2023. 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/ William Yang Compliance Officer Division of Drug Quality II Content current as of: 05/29/2025 Regulated Product(s) Drugs