FDA Inspection 1333460 — Materna Medical
The FDA completed an inspection of Materna Medical on Aug 26, 2026 in Mountain View, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mountain View, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23257 | ISO 13485:2016 Clause 8.5.2 | Corrective actions not proportionate to the effects of nonconformities |