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Ortho Clinical Diagnostics Gmbh MARCS-CMS 457877 —

Medical Devices

Recipient Name
Ms. Gundula Twieling
Recipient Title
General Manager
Ortho Clinical Diagnostics Gmbh

Bahnhof str. 54
69151 Neckargemund

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

United States

Dear Ms. Gundula Twieling:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #457877 dated September 3, 2015. 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.

Elizabeth J.
Hillebrenner -S
for Donald J. St. Pierre
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological

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