Safe Chain Solutions, LLC

CLOSEOUT LETTER Safe Chain Solutions, LLC MARCS-CMS 636044 — March 10, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3009728473 Product: Drugs Recipient: Recipient Name Amanda Biggart and Dakota Flowers Recipient Title Chief Operating Officer/Compliance Manager Safe Chain Solutions, LLC 822 Chesapeake Dr Cambridge , MD 21613-9408 United States 855-437-5727 AmandaB@SafeChain.com DakotaF@SafeChain.com Issuing Office: Division of Pharmaceutical Quality Operations I United States Secondary Issuing Offices United States Dear Ms. Biggart and Ms. Flowers, The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 636044, dated June 8, 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/ Tia Harper-Velazquez, Director Division of Supply Chain Integrity Office of Drug Security, Integrity and Response Office of Compliance Center for Drug Evaluation and Research U.S. Food & Drug Administration Content current as of: 03/17/2025 Regulated Product(s) Drugs