FDA Inspection
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeFUJIFILM Healthcare Manufacturing Corporation Sano Office – FDA Inspection, Jan 27, 2023
Record Details
This FDA Inspection record concerns FUJIFILM Healthcare Manufacturing Corporation Sano Office, with an inspection on January 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 27, 2023
- Product Type
- Devices
View Company Profile
ID · 126169c2-6376-4023-b1af-c3fff3269bd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197046
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of FUJIFILM Healthcare Manufacturing Corporation Sano Office
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FUJIFILM Healthcare Manufacturing Corporation Sano Office
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.