FDA 483 - Figure 8 Surgical, Inc. - December 18, 2019

An FDA inspection of Figure 8 Surgical, Inc. in Morgantown, WV, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to complaint handling, product identification throughout all stages, and design validation. These issues indicate a need for improved procedural controls to ensure compliance with regulatory requirements.