True Function Laboratory, Inc. – FDA 483, Aug 7, 2023

True Function Laboratory, Inc. in La Mesa, CA, a manufacturer of anti-snoring and anti-sleep apnea devices, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures and documentation for complaint handling, equipment control, nonconforming materials, device history records, acceptance activities, corrective and preventive actions, and management review. Several observations were repeats, indicating a systemic lack of compliance with established procedures and regulatory requirements.