FDA Inspection 624829 — Integra Neurosciences
The FDA completed an inspection of Integra Neurosciences on October 22, 2009 in Anasco, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Anasco, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3697 | 21 CFR 820.150(a) | Stock rotation, assessment before release |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |