Deva Holding AS - Cerkezkoy Subesi

CLOSEOUT LETTER Deva Holding AS - Cerkezkoy Subesi MARCS-CMS 577493 — December 23, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 320-19-33 Product: Drugs Recipient: Recipient Name Ms. Refiye Adiyaman Recipient Title Manager, Quality Operations Group Deva Holding AS - Cerkezkoy Subesi Halkalı Merkez Mah. Basın Expres Caddesi No:1 34303 Küçükçekmece / İstanbul Turkey Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Ms. Adiyaman, The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-33 dated August 6, 2019. 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 and/or deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ for Joan Johnson Compliance Officer Division of Drug Quality I Content current as of: 01/12/2023 Regulated Product(s) Drugs