# FDA 483 - Advanced Monitored Caregiving, Inc. - November 12, 2020

Source: https://www.globalkeysolutions.net/records/483/advanced-monitored-caregiving-inc/e4febd6e-1a96-4ef9-aabd-2e7691c7f46d

> FDA 483 for Advanced Monitored Caregiving, Inc. on November 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Monitored Caregiving, Inc.
- Inspection Date: 2020-11-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Advanced Monitored Caregiving, Inc., a medical device manufacturer in New York, NY, was cited for failing to develop and maintain adequate Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures for death and serious injury incidents and instructions for reporting required information on MedWatch Form 3500A. This indicates a significant lapse in critical post-market surveillance and reporting requirements for medical devices.

## Related Documents

- [483 - 2025-01-31](https://www.globalkeysolutions.net/records/483/advanced-monitored-caregiving-inc/908ea610-2971-4409-bf17-fa1b01a865f4)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961