FDA Inspection
Philips North America LLCPhilips North America LLC – FDA Inspection, Apr 21, 2015
Record Details
This FDA Inspection record concerns Philips North America LLC, with an inspection on April 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America LLC
- Inspection Date
- April 21, 2015
- Product Type
- Devices
View Company Profile
ID · dd22636e-8452-4876-b3c4-b8ffe7523737
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 923916
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips North America LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | Seattle District Office | Compliance: Medical Devices |
| November 6, 2024 | Not classified | Seattle District Office | Compliance: Medical Devices |
| November 3, 2023 | Not classified | Seattle District Office | |
| October 27, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Philips North America LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.