FDA Inspection 1327238 — FIGUR8, INC.
The FDA completed an inspection of FIGUR8, INC. on Jul 21, 2026 in Boston, 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23102 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs not determined |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23256 | ISO 13485:2016 Clause 8.5.2 | Corrective actions were unduly delayed |
| 23267 | 21 CFR 820.35(c) | UDI was not recorded for each medical device or batch |