FDA Inspection
Philips Healthcare Informatics, Inc.Philips Healthcare Informatics, Inc. – FDA Inspection, Jul 26, 2011
Record Details
This FDA Inspection record concerns Philips Healthcare Informatics, Inc., with an inspection on July 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 26, 2011
- Product Type
- Devices
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ID · f8c0a13a-6809-4228-b2fb-463f4b9728cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735801
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Philips Healthcare Informatics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 18, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Philips Healthcare Informatics, Inc.
- FDA Inspection 929413 - 2015-06-04
- FDA Inspection 914421 - 2015-02-17
- FDA Inspection 776493 - 2012-04-18
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