Company
United StatesFujifilm Irvine Scientific, Inc., Santa Ana, CA – FDA Inspections
Inspection records and compliance data for Fujifilm Irvine Scientific, Inc. in Santa Ana, California. 2 FDA inspections on record, last inspected July 02, 2014.
Company Profile
This profile covers Fujifilm Irvine Scientific, Inc. based in Santa Ana, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected January 20, 2009. Last inspected July 2, 2014.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Investigation of device failures1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 2, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 886130 |
| January 20, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 561498 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fujifilm Irvine Scientific, Inc.
FEI Number
2022379
Address
2511 Daimler St, Santa Ana, California 92705, United States
Country
United States
ID: a629768f-913e-463a-99fd-11630b18e967