Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S.

CLOSEOUT LETTER Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. MARCS-CMS 659854 — August 14, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Hakan Tuna Recipient Title President/Chairman of the Board Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. No. 32 Omerli Mahallesi, Uran Caddesi 34799 Cekmekoy / İstanbul Turkey Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States Dear Mr. Tuna: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-29 dated August 3, 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/ Reba Gates Compliance Officer Division of Drug Quality II Content current as of: 08/30/2024 Regulated Product(s) Drugs