FDA 483 - Sleepsafe Beds, LLC - October 19, 2023

An FDA inspection of Sleepsafe Beds, LLC in Bassett, VA, a manufacturer of beds, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for acceptance activities, corrective and preventive actions (CAPA), and control of nonconforming products. Additionally, software used in production was not adequately validated, indicating a broad lack of adherence to quality system requirements.