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

Source: https://www.keypedia.com/records/483/advanced-ambulatory-inc/b1771f00-0b82-4710-bcb3-b7ad6f3445d1

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

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## Details

- Record Type: 483
- Company Name: Advanced Ambulatory, Inc.
- Inspection Date: 2024-07-31
- Product Type: devices
- Office Name: Dallas District Office
- Summary: During an FDA inspection conducted from July 16-31, 2024, Advanced Ambulatory, Inc., a medical device manufacturer in Houston, TX, received a Form FDA-483 citing significant deficiencies in its quality management system, primarily concerning their AqueCool devices. The company was found to be in violation of several FDA regulations for medical devices.

Key issues included inadequate procedures for receiving, reviewing, and evaluating customer complaints, with many cases lacking investigations or essential details, and some complaints not being properly logged. The firm also failed to establish adequate process controls for reusable device processing and repair documentation, and lacked written acceptance criteria for finished AqueCool Masks. A major finding was the absence of validation for critical manufacturing processes, such as cleaning, adhesive setting, bladder manufacturing, and overall system validation.

Further observations highlighted deficiencies in equipment calibration and maintenance, an unclear process for evaluating post-production design changes, and outdated, incomplete risk analysis documents. The company also demonstrated inadequate document control, failed to maintain complete records for its internal quality audits, and lacked comprehensive Medical Device Reporting (MDR) procedures, including specific reporting timeframes. Advanced Ambulatory, Inc. has committed to addressing most of these observations through corrective actions, with one item currently under consideration, to ensure compliance with medical device quality system requirements.

## Related Documents

- [483 - 2024-07-31](https://www.keypedia.com/records/483/advanced-ambulatory-inc/28853092-3ffb-4f83-9936-768df93ea1b3)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9