FDA Inspection 1246776 — AVITA MEDICAL AMERICAS LLC
The FDA completed an inspection of AVITA MEDICAL AMERICAS LLC on August 7, 2024 in Valencia, 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
- August 7, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |