FDA Inspection
Radiant Express LLCRadiant Express LLC – FDA Inspection, Feb 18, 2015
Record Details
This FDA Inspection record concerns Radiant Express LLC, with an inspection on February 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Radiant Express LLC
- Inspection Date
- February 18, 2015
- Product Type
- Devices
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ID · 14cc7499-813c-4e61-87ea-40a8c01a5288
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 914376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Radiant Express LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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