FDA Inspection
Horiba ABX SASHoriba ABX SAS – FDA Inspection, Jun 9, 2011
Record Details
This FDA Inspection record concerns Horiba ABX SAS, with an inspection on June 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Horiba ABX SAS
- Inspection Date
- June 9, 2011
- Product Type
- Devices
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ID · 222d825d-b060-4e9c-b880-868d94b69474
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734470
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Horiba ABX SAS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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