FDA Inspection 863382 — Cardiac Assist, Inc
The FDA completed an inspection of Cardiac Assist, Inc on February 7, 2014 in Pittsburgh, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3115 | 21 CFR 820.70(h) | Use and removal, Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 537 | 21 CFR 820.70(a) | Production processes |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |