Advanced Ambulatory, Inc. – FDA 483, Jul 31, 2024

Advanced Ambulatory, Inc., a medical device manufacturer in Houston, TX, received a Form FDA 483 with 10 observations following an inspection from July 16-31, 2024. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, process control, finished device acceptance, process validation, equipment calibration, design change, risk management, document control, quality audits, and Medical Device Reporting. These issues indicate a systemic lack of established and maintained quality system controls for their AqueCool devices and masks.