CLOSEOUT LETTER
Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa MARCS-CMS 649158 —
- Delivery Method:
- Via Email
- Product:
- Medical Devices
- Recipient:
-
Recipient NameMehmet Kayabaş
-
Recipient TitleCo-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
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