FDA Inspection
Neoventa Medical ABNeoventa Medical AB – FDA Inspection, Apr 1, 2010
Record Details
This FDA Inspection record concerns Neoventa Medical AB, with an inspection on April 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neoventa Medical AB
- Inspection Date
- April 1, 2010
- Product Type
- Devices
View Company Profile
ID · 863ee3e7-8abf-4a0a-af4f-1851dff22ce4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 658312
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 820.198(e)(2)Date complaint received
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.100(a)(4)Verify, validate change {see also 820.100(a)}
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Other FDA inspections of Neoventa Medical AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neoventa Medical AB
- FDA Inspection 709564 - 2011-02-10
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