Nephron SC, LLC

CLOSEOUT LETTER Nephron SC, LLC MARCS-CMS 634647 — May 08, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3010892830 Product: Drugs Recipient: Recipient Name Ms. Lou W. Kennedy Recipient Title Chief Executive Officer Nephron SC, LLC 4500 12th Street Ext. West Columbia , SC 29172 United States Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Secondary Issuing Offices United States Dear Ms. Kennedy: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case # 634647 dated October 11, 2022. 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/ Michael Klapal Consumer Safety Officer Office of Manufacturing Quality Content current as of: 05/18/2026 Regulated Product(s) Drugs