FDA Inspection
DIO USADIO USA – FDA Inspection, Nov 16, 2009
Record Details
This FDA Inspection record concerns DIO USA, with an inspection on November 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DIO USA
- Inspection Date
- November 16, 2009
- Product Type
- Devices
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ID · 70af05af-82ca-468c-9977-e483c329a8d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 627607
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of DIO USA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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