FDA Inspection 1056032 — Origami Surgical LLC
The FDA completed an inspection of Origami Surgical LLC on Jun 14, 2018 in Madison, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 14, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Madison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |