FDA Inspection 1325004 — AZURE BIOSYSTEMS INC.
The FDA completed an inspection of AZURE BIOSYSTEMS INC. on Jul 2, 2026 in Dublin, CA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dublin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23141 | ISO 13485:2016 Clause 7.4.1 | Supplier monitoring and re-evaluation not planned |
| 23151 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities are inadequate |
| 23172 | ISO 13485:2016 Clause 7.5.6 | Computer software used in production and service provision not validated |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |