Comac Medical has the pleasure to announce that our Clinical Research Unit has successfully passed a pre-approval inspection from the US Food and Drug Administration (FDA).
The scheduled US FDA visit lasted 5 days – between 10th and 14th of February 2020; as a result, no FDA Form 483 has been issued.
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.
The successful US FDA inspection of Comac Medical’s Clinical Research Unit facilities reflects the company’s commitment to deliver the highest quality services.
“The inspected study enrolled 70 patients and successfully passed US FDA inspection once again confirms that the highest quality standards are followed”, stated Tsvetelina Ivanova, Comac Medical’s Chief Compliance Officer.
“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.