FDA Inspection 922868 — FUJIFILM Healthcare Americas Corporation
The FDA completed an inspection of FUJIFILM Healthcare Americas Corporation on April 9, 2015 in Wayne, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 9, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |