FDA Inspection
Fujifilm Irvine Scientific, Inc.Fujifilm Irvine Scientific, Inc. – FDA Inspection, Jul 2, 2014
Record Details
This FDA Inspection record concerns Fujifilm Irvine Scientific, Inc., with an inspection on July 2, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 2, 2014
- Product Type
- Devices
View Company Profile
ID · d6fe786c-7cd2-4b2d-83b1-a1f25f39d07e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886130
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fujifilm Irvine Scientific, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fujifilm Irvine Scientific, Inc.
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.