FDA Inspection 1205080 — MICROVENTION INC.
The FDA completed an inspection of MICROVENTION INC. on May 4, 2023 in Aliso Viejo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aliso Viejo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |