FDA Inspection 658312 — Neoventa Medical AB
The FDA completed an inspection of Neoventa Medical AB on April 1, 2010 in Molndal. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 1, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Molndal (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3376 | 21 CFR 820.198(e)(2) | Date complaint received |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 4189 | 21 CFR 820.198(a) | General |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |