483
Rejoni, Inc.Rejoni, Inc. – FDA 483, Jul 9, 2025
Record Details
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.
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ID · 551c51a6-adb5-4148-aae4-8a568a1ffa60
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