FDA Inspection 775687 — Bionik, Inc.
The FDA completed an inspection of Bionik, Inc. on April 3, 2012 in Watertown, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Watertown, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |