FDA 483 - VertiFlex, Inc. - July 25, 2014

An FDA inspection of Vertiflex, Inc. in San Clemente, CA, revealed significant deficiencies in record-keeping for investigational devices. The firm failed to maintain accurate and complete records for PMA data, specifically regarding surgical approach procedures, and exhibited widespread inaccuracies and incompleteness in device accountability and disposition records for explanted and returned devices.