FDA Inspection
Philips Medizin Systeme Boeblingen GmbhPhilips Medizin Systeme Boeblingen Gmbh – FDA Inspection, Sep 23, 2010
Record Details
This FDA Inspection record concerns Philips Medizin Systeme Boeblingen Gmbh, with an inspection on September 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 23, 2010
- Product Type
- Devices
View Company Profile
ID · 79bdbabe-0ee5-47d3-9fc9-a3d833d7e40e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682310
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips Medizin Systeme Boeblingen Gmbh
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 24, 2017 | Not classified | Office of Inspections and Investigations | |
| January 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips Medizin Systeme Boeblingen Gmbh
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.