FDA Inspection
Horiba Instruments IncorporatedHoriba Instruments Incorporated – FDA Inspection, Apr 8, 2009
Record Details
This FDA Inspection record concerns Horiba Instruments Incorporated, with an inspection on April 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 8, 2009
- Product Type
- Devices
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ID · 9cf76fa1-2ff3-4e99-bc0a-fe1e23077fdc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 577506
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(c)Design input procedures - appropriateness
- 21 CFR 820.22Quality audit corrective action, reaudits {see also 820.100}
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Horiba Instruments Incorporated
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 30, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 28, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Horiba Instruments Incorporated
- FDA Inspection 1031100 - 2017-10-31
- FDA Inspection 931697 - 2015-06-30
- FDA Inspection 815527 - 2013-01-24
- FDA Inspection 782820 - 2012-03-09
- FDA Inspection 706493 - 2011-01-28
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