FDA 483 - APEX DENTAL SLEEP LAB LLC - February 22, 2024

An FDA inspection of APEX DENTAL SLEEP LAB LLC in La Mesa, CA, a manufacturer of dental sleep devices, revealed significant deficiencies in its quality system. Observations included inadequate documentation of corrective and preventive actions, lack of procedures for rework of nonconforming products, and insufficient complaint handling processes. Additionally, the firm failed to include Unique Device Identifiers (UDI) on its finished medical device labels.