FDA Inspection 1301914 — BioSensics LLC
The FDA completed an inspection of BioSensics LLC on February 9, 2026 in Newton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23236 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not identified and controlled |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |