FDA Inspection
FujiFilm Healthcare Americas CorporationFujiFilm Healthcare Americas Corporation – FDA Inspection, Feb 6, 2017
Record Details
This FDA Inspection record concerns FujiFilm Healthcare Americas Corporation, with an inspection on February 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · d187ec97-a549-498d-a2f9-8b8d1c1c624a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000709
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of FujiFilm Healthcare Americas Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 1, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for FujiFilm Healthcare Americas Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.