FDA 483 - Imbed Biosciences, Inc. - February 14, 2025

Imbed Biosciences Inc. in Middleton, WI, was inspected by the FDA from February 10-14, 2025. The inspection revealed significant issues with the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to follow its own written procedures regarding timely closure of CAPAs and verification of corrective actions, indicating a moderate level of non-compliance with quality system requirements.