FDA Inspection 598380 — Vygon US LLC D/B/A Vygon Neuro
The FDA completed an inspection of Vygon US LLC D/B/A Vygon Neuro on Jun 26, 2009 in Norristown, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Norristown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |