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CLOSEOUT LETTER

QLRAD Netherlands MARCS-CMS 510526 —

Product:
Medical Devices

Recipient:
Recipient Name
Arjen Winkel
Recipient Title
President and CEO
QLRAD Netherlands
HOSPIMED

Rietveldstraat 22
Zwolle
8013RW Overijssel
Netherlands

awinkel@qlrad.com
Issuing Office:
Center for Devices and Radiological Health

United States


Dear Mr. Winkel,

The Food and Drug Administration has completed an evaluation of QLRAD’s corrective actions in response to our Warning Letter (CMS #510526, dated July 20, 2017). 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, PhD 
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health


Cc:
EA Winkel
QLRAD Inc.
HYH 9107 NW 105th Way
Medley, Florida 33178

 
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