FDA Inspection
RDI Inc.RDI Inc. – FDA Inspection, Jun 10, 2019
Record Details
This FDA Inspection record concerns RDI Inc., with an inspection on June 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 890ca456-abec-473d-b30e-2a6bb49ff246
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092436
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RDI Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for RDI Inc.
- FDA Inspection 1261930 - 2025-02-13
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