FDA Inspection 1318162 — Biomerics Precision Concepts Group
The FDA completed an inspection of Biomerics Precision Concepts Group on May 21, 2026 in Winston Salem, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winston Salem, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |