Alphatec Spine, Inc. – FDA 483, Mar 13, 2015

An FDA inspection of Alphatec Spine, Inc. in Carlsbad, CA, revealed significant quality system deficiencies, particularly concerning medical device reporting and design controls. The firm failed to submit numerous malfunction reports for its Illico Screw Extender and lacked proper design validation and history files for acquired spinal implant devices. Additionally, procedures for corrective and preventive actions, design validation, and acceptance activities were found to be inadequately established or defined.