Safecor Health, LLC

CLOSEOUT LETTER Safecor Health, LLC MARCS-CMS 657886 — January 17, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Stephen T. Fischbach Recipient Title President and Chief Executive Officer Safecor Health, LLC 4060 Business Park Drive Columbus , OH 43204 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States Secondary Issuing Offices United States Dear Mr. Fischbach: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 657886 dated September 5, 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/ Jamie Dion Compliance Officer Division of Drug Quality II Content current as of: 02/10/2025 Regulated Product(s) Drugs