FDA 483 - Spineway - July 18, 2019

Spineway, a medical device manufacturer in Ecully, France, was inspected by the FDA from July 15-18, 2019. The inspection revealed two significant issues: inadequate procedures for corrective and preventive actions (CAPA) and a failure to submit a Medical Device Report (MDR) within the required 30-day timeframe for a serious injury event. These observations indicate deficiencies in the firm's quality system and regulatory reporting compliance.