# FDA 483 - Lifebridge Health, Inc. IRB - March 11, 2026

Source: https://www.keypedia.com/records/483/lifebridge-health-inc-irb/ee7d120e-feb2-42ea-933d-f067eeb1d895

> FDA 483 for Lifebridge Health, Inc. IRB on March 11, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lifebridge Health, Inc. IRB
- Inspection Date: 2026-03-11
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Lifebridge Health, Inc. IRB in Baltimore, MD, revealed a significant deficiency in their review process. The Institutional Review Board failed to document required determinations for studies involving children, specifically regarding compliance with 21 CFR 50 Subpart D. This indicates a lapse in ensuring additional safeguards for vulnerable populations in clinical investigations.

## Related Officers

- [Cynthia L. Rakestraw](https://www.keypedia.com/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.keypedia.com/companies/lifebridge-health-inc-irb/6c2de5fb-a990-4371-bbe3-190528cbf652

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e