FDA Inspection 684575 — Event Medical LTD
The FDA completed an inspection of Event Medical LTD on October 8, 2010 in Lake Forest, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |