FDA 483 - Spirus Medical, LLC - November 18, 2022

Spirus Medical, LLC in West Bridgewater, MA was inspected by the FDA from November 15-18, 2022. The inspection revealed a significant issue with the firm's complaint handling procedures. Specifically, the firm's procedures were not adequately established, with deficiencies noted in documentation, record usage, required signatures, and the recording of unique device identifiers for products.