Consolidated Research, Inc. DBA General Sleep Corporation – FDA 483, Mar 25, 2026

Consolidated Research, Inc., a medical device manufacturer in Euclid, OH, received a Form FDA 483 with seven observations highlighting significant deficiencies in its quality management system. Key issues include inadequate risk management, failure to implement and document corrective actions for recurring device failures, poor record-keeping for rework activities, and insufficient supplier evaluation and monitoring. Additionally, the firm lacks a quality manual and has incorrect Unique Device Identifier (UDI) information submitted to the FDA.