# Rejoni, Inc. – FDA 483, Jul 9, 2025

Source: https://www.keypedia.com/records/483/rejoni-inc/551c51a6-adb5-4148-aae4-8a568a1ffa60

> FDA 483 for Rejoni, Inc. on July 09, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rejoni, Inc.
- Inspection Date: 2025-07-09
- Product Type: other
- Office Name: New England District Office
- Summary: An FDA inspection of Rejoni, Inc. in Bedford, MA, identified a significant issue regarding their investigational plan. The firm failed to obtain required FDA and IRB approval for changes to an investigational plan, specifically concerning the lack of independent assessment of primary efficacy endpoints by the Central Review Committee. The Medical Monitor, with unblinded access, influenced blinded CRC members' assessments, potentially compromising study integrity.

## Related Officers

- [Meredith L. Miller](https://www.keypedia.com/people/meredith-l-miller/c775003b-4e5b-48d8-bc51-1a3ebe813dba)

Company: https://www.keypedia.com/companies/rejoni-inc/5dfbfff9-b468-4479-b150-e9bcd65e8116

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144