FDA Inspection 653440 — Cardiac Science Corporation
The FDA completed an inspection of Cardiac Science Corporation on Mar 22, 2010 in Laguna Hills, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Laguna Hills, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |