FDA Inspection 1046796 — FUJIFILM Healthcare Americas Corporation
The FDA completed an inspection of FUJIFILM Healthcare Americas Corporation on March 29, 2018 in Lexington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Lexington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5008 | 21 CFR 1002.20(a) | Failure to report |