FDA Inspection
Rejoni, Inc.Rejoni, Inc. – FDA Inspection, Jul 9, 2025
Record Details
This FDA Inspection record concerns Rejoni, Inc., with an inspection on July 9, 2025, issued by the New England District Office, covering medical devices & rad health.
- Person
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ID · 7794bdb2-3d74-4206-b877-69bfddc671cd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1275287
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
1- 21 CFR 812.35(a)(1)No approval for changes requiring prior approval
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Other FDA inspections of Rejoni, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2026 | NAI | Compliance: Devices |
Other documents for Rejoni, Inc.
- FDA Inspection 1302726 - 2026-02-09
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