FDA Inspection 1275287 — Rejoni, Inc.
The FDA completed an inspection of Rejoni, Inc. on July 9, 2025 in Bedford, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 9, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bedford, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14517 | 21 CFR 812.35(a)(1) | No approval for changes requiring prior approval |