FDA Inspection 1311222 — NATERA, INc
The FDA completed an inspection of NATERA, INc on April 6, 2026 in Austin, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |