FDA 483 - Apnea Sciences Corporation - August 19, 2021

Apnea Sciences Corporation, a medical device manufacturer in Aliso Viejo, CA, was inspected by the FDA from August 16-19, 2021. The inspection revealed significant deficiencies in their quality system, specifically regarding corrective and preventive actions, device history records, and acceptance activities documentation. These issues indicate a lack of adherence to established procedures and regulatory requirements for medical device manufacturing.