FDA 483 - Globus Medical, Inc. - September 27, 2019

Globus Medical, Inc. in Audubon, PA, was inspected by the FDA, resulting in seven observations. The inspection revealed significant issues with record-keeping and documentation for HCT/P distribution, including unrecorded storage temperatures. Additionally, the firm had inadequate procedures for controlling nonconforming products, establishing corrective and preventive actions, ensuring personnel training, and maintaining document control.