FDA Inspection 919044 — FUJIFILM Healthcare Americas Corporation
The FDA completed an inspection of FUJIFILM Healthcare Americas Corporation on February 19, 2015 in Lexington, MA. 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
- February 19, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lexington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |