FDA Inspection 1335880 — BIONICM
The FDA completed an inspection of BIONICM on Aug 20, 2026 in Bunkyo. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bunkyo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 23216 | ISO 13485:2016 Clause 8.2.2 | Lack of documented justification for not investigating complaint(s) |