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CLOSEOUT LETTER

DRG Instruments GmbH MARCS-CMS 522669 —

Product:
Medical Devices
Recipient:
Recipient Name
Dr. Bernd Rӧder
Recipient Title
Head of Regulatory Affairs
DRG Instruments GmbH

Frauenbergstraβe 18
35039 Marburg
Germany

Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"

United States

Dear Dr. Rӧder:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 522669, dated 10/17/2017). 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/
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Quality
OHT7: Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and Radiological Health

CC:

Ina Hairston
DRG International, Inc.
841 Mountain Avenue
Springfield , NJ US 07081
Email: qa@drg-international.com

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