FDA Inspection 629437 — Thoratec Corporation
The FDA completed an inspection of Thoratec Corporation on October 13, 2009 in Burlington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 13, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3670 | 21 CFR 820.20(c) | Management review participants |