# FDA 483 - Advanced Monitored Caregiving, Inc. - January 31, 2025

Source: https://www.keypedia.com/records/483/advanced-monitored-caregiving-inc/908ea610-2971-4409-bf17-fa1b01a865f4

> FDA 483 for Advanced Monitored Caregiving, Inc. on January 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Monitored Caregiving, Inc.
- Inspection Date: 2025-01-31
- Product Type: device
- Office Name: New York District Office
- Summary: Advanced Monitored Caregiving, Inc. in New York, a software manufacturer, received a Form FDA 483 for significant deficiencies in its quality system. The inspection revealed issues with the design history file for its CareConsole software platform, including a lack of design plans, formal reviews, and proper verification and validation activities. Additionally, the firm failed to provide justification for not reporting a device correction to the FDA and demonstrated inadequate complaint handling procedures, particularly concerning Medical Device Reporting assessments.

## Related Documents

- [483 - 2020-11-12](https://www.keypedia.com/records/483/advanced-monitored-caregiving-inc/e4febd6e-1a96-4ef9-aabd-2e7691c7f46d)

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/advanced-monitored-caregiving-inc/086808f8-43ff-4ae7-ab94-885c48e8701f

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d