# FDA 483 - Foresite Healthcare LLC - February 13, 2025

Source: https://www.keypedia.com/records/483/foresite-healthcare-llc/701acecd-91e0-4efe-a4f0-0f15cbd6dc0e

> FDA 483 for Foresite Healthcare LLC on February 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foresite Healthcare LLC
- Inspection Date: 2025-02-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Foresite Healthcare LLC in Maryland Heights, MO, revealed significant deficiencies in its quality system and complaint handling processes for its DS6 depth sensor device. The firm failed to promptly review and investigate MDR-reportable complaints, lacked essential quality system procedures, and did not register its laser-containing medical device with the FDA. These issues indicate a serious lack of control over device manufacturing and post-market surveillance.

## Related Documents

- [483 - 2025-02-13](https://www.keypedia.com/records/483/foresite-healthcare-llc/1149c736-5f78-469a-a107-cc8a50c6cab7)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/foresite-healthcare-llc/4a8e80b0-520f-4acf-8e68-9916f2e7c278

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8