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CLOSEOUT LETTER

Safe Chain Solutions, LLC MARCS-CMS 636044 —

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

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