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MC “Comac Medical” receives NAI Letter from the FDA
October 12, 2020

After successfully passing a pre-approval FDA inspection, Comac Medical’s Clinical Research Unit has been honored with a NAI certificate.

The scheduled US FDA visit lasted 5 days – between 10th and 14th of February 2020. During the inspection, the Clinical Research Unit was checked for compliance with the US FDA requirements. The inspection included extensive review of documentation, and no FDA Form 483 has been issued.

After the inspection, the FDA determined that the areas evaluated are in compliance with applicable laws and regulations. The FDA and the Inspection Classification Database classified the inspection with NAI, which means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).

“Thank you all for doing a fantastic job!”, commented the Vice-President of the Sponsor of the inspected study, congratulating the whole Comac Medical team.

The blinded NAI Letter can be obtained from the  Certifications page  on the Comac Medical website.

 

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