FDA Inspection
Philips North America LLCPhilips North America LLC – FDA Inspection, Aug 9, 2010
Record Details
This FDA Inspection record concerns Philips North America LLC, with an inspection on August 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America LLC
- Inspection Date
- August 9, 2010
- Product Type
- Devices
View Company Profile
ID · f1e6c6e7-273c-4fb4-907b-e12ff3543bc9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 803.52(f)(1)Type of Reportable Event
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Software validation for automated processes
Showing 10 of 11 citations.
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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 |
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