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  5. Fischer Analysen Instrumente Gmbh - 650388 - 07/08/2024
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CLOSEOUT LETTER

Fischer Analysen Instrumente Gmbh MARCS-CMS 650388 —

Product:
Medical Devices
Recipient:
Recipient Name
Dr. Martin Schaich
Recipient Title
Managing Director
Fischer Analysen Instrumente Gmbh

Brahestr. 25-27
04347 Leipzig, Saxony
Germany

Martin.Schaich@fan-gmbh.de
Issuing Office:
Center for Devices and Radiological Health

United States

Secondary Issuing Offices

United States

Dear Dr. Martin Schaich:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 650388, dated February 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 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/
Courtney H. Lias, Ph.D. Acting Director
OHT7: Office of In Vitro Diagnostic Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
US AGENT:
Philip Ross
Gulf Coast Scientific, Inc. / ARJ Medical, Inc.
209 State Street E.
Oldsmar, FL US 34677
Email: PRoss@Gulfcoastscientific.com

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