FDA Inspection
Horiba ABX SASHoriba ABX SAS – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns Horiba ABX SAS, with an inspection on June 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a95921d5-8f4c-4ccd-b511-4a1f4f93c1fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018230
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Horiba ABX SAS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Horiba ABX SAS
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.