Company
GermanyPhilips Medizin Systeme Boeblingen Gmbh, Boblingen, Germany – FDA Inspections
Inspection records and compliance data for Philips Medizin Systeme Boeblingen Gmbh in Boblingen. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 07, 2024.
Company Profile
This profile covers Philips Medizin Systeme Boeblingen Gmbh based in Boblingen, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 23, 2010. Last inspected March 7, 2024.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR content1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1230548 |
| November 24, 2017 | Not classified | Medical Devices & Rad Health | 1050977 |
| January 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 913852 |
| June 14, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 791970 |
| September 23, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 682310 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Philips Medizin Systeme Boeblingen Gmbh
FEI Number
3002807167
Address
Hewlett-Packard-Str. 2, Boblingen, Germany
Country
Germany
ID: 736b3a4d-eb04-4b84-832d-87925302302a