FDA Inspection
Philips Ultrasound, Inc.Philips Ultrasound, Inc. – FDA Inspection, Dec 9, 2011
Record Details
This FDA Inspection record concerns Philips Ultrasound, Inc., with an inspection on December 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips Ultrasound, Inc.
- Inspection Date
- December 9, 2011
- Product Type
- Devices
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ID · 51fecd2b-2e1f-4c13-89af-c20ab779a51c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 761739
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips Ultrasound, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | OAI | Seattle District Office | Compliance: Medical Devices |
| November 10, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2019 | Not classified | Seattle District Office | |
| August 17, 2017 | Not classified | Seattle District Office |
Other documents for Philips Ultrasound, Inc.
- FDA Inspection 1253946 - 2025-01-31
- FDA Inspection 1157069 - 2021-11-10
- FDA Inspection 1157003 - 2019-07-25
- FDA Inspection 1028990 - 2017-08-17
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