FDA Inspection
Philips Ultrasound, Inc.Philips Ultrasound, Inc. – FDA Inspection, Jan 31, 2025
Record Details
This FDA Inspection record concerns Philips Ultrasound, Inc., with an inspection on January 31, 2025, issued by the Seattle District Office, covering medical devices & rad health.
- Company
- Philips Ultrasound, Inc.
- Inspection Date
- January 31, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 49199735-78fa-44ec-9fd3-c809697e64c2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1253946
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued, view the record
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips Ultrasound, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 | |
| December 9, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Philips Ultrasound, Inc.
- FDA Inspection 1157069 - 2021-11-10
- FDA Inspection 1157003 - 2019-07-25
- FDA Inspection 1028990 - 2017-08-17
- FDA Inspection 761739 - 2011-12-09
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