FDA Inspection 948389 — Thoratec LLC
The FDA completed an inspection of Thoratec LLC on November 23, 2015 in Pleasanton, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 23, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pleasanton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |