FDA Inspection
Horiba Instruments IncorporatedHoriba Instruments Incorporated – FDA Inspection, May 16, 2013
Record Details
This FDA Inspection record concerns Horiba Instruments Incorporated, with an inspection on May 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 16, 2013
- Product Type
- Devices
View Company Profile
ID · 82a8add5-c28e-4e20-ab14-0b9fc2b8f7e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.40(a)Report of death, injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Horiba Instruments Incorporated
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 13, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Horiba Instruments Incorporated
- FDA Inspection 771894 - 2012-03-01
- FDA Inspection 712341 - 2011-02-07
- FDA Inspection 671861 - 2010-07-13
- FDA Inspection 598173 - 2009-07-16
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