# FDA 483 - Advanced Ambulatory, Inc. - July 31, 2024

Source: https://www.globalkeysolutions.net/records/483/advanced-ambulatory-inc/28853092-3ffb-4f83-9936-768df93ea1b3

> FDA 483 for Advanced Ambulatory, Inc. on July 31, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Advanced Ambulatory, Inc.
- Inspection Date: 2024-07-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/advanced-ambulatory-inc/286d3111-3bbb-4a17-9f0d-e2b40313b6d3

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab