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  5. Fehling Instruments GmbH & Co. KG - 479523 - 08/21/2019
  1. Warning Letters

CLOSEOUT LETTER

Fehling Instruments GmbH & Co. KG MARCS-CMS 479523 —

Product:
Medical Devices
Recipient:
Recipient Name
Gerald Fehling
Recipient Title
CEO
Fehling Instruments GmbH & Co. KG

Hanauer Landstr. 7
63791 Karlstein a. Main
Germany

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Mr. Fehling:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 479523, dated October 13, 2015). Based on our evaluation, it appears that you have addressed the violation(s) 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 yours,
/S/
Bram Zuckerman, MD
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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