FDA Inspection 1197046 — FUJIFILM Healthcare Manufacturing Corporation Sano Office
The FDA completed an inspection of FUJIFILM Healthcare Manufacturing Corporation Sano Office on January 27, 2023 in Sano. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sano (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |