FDA Inspection 1102363 — Conformis, Inc.
The FDA completed an inspection of Conformis, Inc. on September 20, 2019 in Billerica, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 20, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |