CLOSEOUT LETTER
Deymed Diagnostic s.r.o. MARCS-CMS 671076 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameKamil Holub
-
Recipient TitleCEO
- Deymed Diagnostic s.r.o.
Kudrnacova 533
Hronov
54931 Nachod
Czechia
- Issuing Office:
- OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
United States
United States
Dear Kamil Holub:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 671076, dated November 7, 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 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/
for David McMullen, M.D.
Director OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Robert V. Packard (U.S. Agent)
Medical Device Academy Inc.
Shrewsbury, VT US 05738
Email: Rob@13485cert.com