Company
United StatesHoriba Instruments Incorporated, Irvine, CA – FDA Inspections
Inspection records and compliance data for Horiba Instruments Incorporated in Irvine, California. 5 FDA inspections on record (1 OAI), last inspected May 16, 2013.
Company Profile
This profile covers Horiba Instruments Incorporated based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected July 16, 2009. Last inspected May 16, 2013.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Report of death, injury1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 16, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 835525 |
| March 1, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 771894 |
| February 7, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 712341 |
| July 13, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 671861 |
| July 16, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 598173 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Horiba Instruments Incorporated
FEI Number
3002698356
Address
9755 Research Dr, Irvine, California 92618, United States
Country
United States
ID: 5821690b-d857-4726-ba06-f67cfd40afb0