FDA Inspection 1313620 — Astura Medical
The FDA completed an inspection of Astura Medical on April 23, 2026 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |