# FDA 483 - Foresight Imaging, LLC - December 20, 2022

Source: https://www.globalkeysolutions.net/records/483/foresight-imaging-llc/0ed2a4ea-3afe-47b0-ad87-a421edbc050c

> FDA 483 for Foresight Imaging, LLC on December 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foresight Imaging, LLC
- Inspection Date: 2022-12-20
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Foresight Imaging, LLC, a medical device manufacturer in Chelmsford, MA, received a Form FDA 483 with two observations. The firm failed to adequately establish procedures for receiving and evaluating complaints, specifically regarding Medical Device Reporting (MDR) evaluations, which was noted as a repeat observation. Additionally, the design history file for their "TIMS MVP" device was not adequately maintained.

## Related Documents

- [483 - 2025-12-12](https://www.globalkeysolutions.net/records/483/foresight-imaging-llc/d3e2dd2d-7dd7-477c-b138-613df66504d1)

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/foresight-imaging-llc/539432cc-c566-422a-88ee-6ecee74ddede

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94