FDA Inspection 772501 — Thoratec Corporation
The FDA completed an inspection of Thoratec Corporation on March 16, 2012 in Burlington, MA. 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
- March 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |