FDA Inspection 982822 — Foundation Medicine, Inc.
The FDA completed an inspection of Foundation Medicine, Inc. on Aug 22, 2016 in Cambridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |