FDA 483 - Cadence Science, Inc. - September 13, 2019

Cadence Science, Inc. in Cranston, RI, was inspected and cited for significant failures in reporting device-related issues. The firm failed to report a field safety advisory notice for pressure control syringes and did not submit a required 5-day report for a medical device reportable event involving syringe breakage. These failures indicate serious lapses in post-market surveillance and reporting requirements for medical devices.