FDA Inspection 567177 — Lucas Medical, Inc.
The FDA completed an inspection of Lucas Medical, Inc. on Feb 24, 2009 in Orange, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orange, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 4189 | 21 CFR 820.198(a) | General |