FDA Inspection 1321370 — Anexa Biomedical, Inc.
The FDA completed an inspection of Anexa Biomedical, Inc. on Jun 10, 2026 in North Richland Hills, TX. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Richland Hills, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |