FDA Inspection
Radparts.comRadparts.com – FDA Inspection, Sep 28, 2010
Record Details
This FDA Inspection record concerns Radparts.com, with an inspection on September 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Radparts.com
- Inspection Date
- September 28, 2010
- Product Type
- Devices
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ID · 959b7cb2-7ecc-4715-bd35-2f64848a5731
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 684100
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Radparts.com
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Radparts.com
- FDA Inspection 782909 - 2012-05-23
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