Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa

CLOSEOUT LETTER Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa MARCS-CMS 649158 — July 10, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Medical Devices Recipient: Recipient Name Mehmet Kayabaş Recipient Title Co-Founder & Chairman of the Board Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa Akcaburgaz Mahallesi, Muhsin Yazicioglu Caddesi No:45/5 34522 Esenyurt / İstanbul Turkey mehmet.kayabas@turkuazsaglik.com.tr Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Kayabaş: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS # 649158, dated December 29, 2022. 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 Agency 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/ Robert Ochs, Ph.D. Director OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Michael Scott ST&T Research International, Inc. 88 McFaul Way Zephyr Cove, Nevada 89448 mscott@sttresearch.com Content current as of: 07/21/2025 Regulated Product(s) Medical Devices