FDA Inspection 1219107 — Fujifilm Corporation
The FDA completed an inspection of Fujifilm Corporation on September 22, 2023 in Ashigarakami-Gun. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ashigarakami-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 738 | 21 CFR 803.52(a)(1) | Patient Name or Other Identifier |
| 771 | 21 CFR 803.52(e)(1) | Contact Office Name and Address |