FDA Inspection 1044469 — BioSensics LLC
The FDA completed an inspection of BioSensics LLC on March 16, 2018 in Newton, 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
- March 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |