FDA Inspection 768206 — Cardiocommand Inc.
The FDA completed an inspection of Cardiocommand Inc. on February 17, 2012 in Tampa, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 17, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |