FDA Inspection
RGIRGI – FDA Inspection, Sep 23, 2026
Record Details
This FDA Inspection record concerns RGI, with an inspection on September 23, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RGI
- Inspection Date
- September 23, 2026
- Product Type
- Devices
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ID · ff5d5274-154c-4545-bead-cb55efaba105
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336996
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RGI
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | Not classified | Detroit District Office |
Other documents for RGI
- FDA Inspection 1242005 - 2024-06-13
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