FDA Inspection 706457 — FUJIFILM Healthcare Americas Corporation
The FDA completed an inspection of FUJIFILM Healthcare Americas Corporation on December 13, 2010 in Wayne, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |