Successful US FDA Audit
Creaspine is pleased to announce that the Food & Drug Administration (FDA) successfully audited their facility in Bordeaux (France)The auditor's report went out positive with no FDA-483 and not a single observation, which stands as an excellent performance for a young company.
The basis of the initial audit was to determine whether policies and practices met the high standards requiered by the US government for the import of Medical Devices into their country.
The Audit was conducted over 4 days, from July 27 to 30, 2009. The four majour QSIT subsystems were covered during the inspection.
"We are very pleased with the results of the recent FDA Audit. It demonstrates the strong commitment of all employees, to the Quality system and the Quality of Devices we commercialise. This Audit confirms the excellence of the foundation we created to carry the development of innovative products" said Philippe Jenny, President of Creaspine.
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