Company
United StatesPhilips Healthcare Informatics, Inc., Pleasanton, CA – FDA Inspections
Inspection records and compliance data for Philips Healthcare Informatics, Inc. in Pleasanton, California. 4 FDA inspections on record, last inspected June 04, 2015.
Company Profile
This profile covers Philips Healthcare Informatics, Inc. based in Pleasanton, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected July 26, 2011. Last inspected June 4, 2015.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 4, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 929413 |
| February 17, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 914421 |
| April 18, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 776493 |
| July 26, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 735801 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Philips Healthcare Informatics, Inc.
FEI Number
3002971142
Address
4430 Rosewood Dr Ste 200, Pleasanton, California 94588, United States
Country
United States
ID: 37d42d8e-fa41-4ef5-b3f8-782e6b391b6b