FDA Inspection
Philips North America LLCPhilips North America LLC – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Philips North America LLC, with an inspection on November 3, 2023, issued by the Seattle District Office.
- Company
- Philips North America LLC
- Inspection Date
- November 3, 2023
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ID · a9ddc856-50d9-4428-a4c8-6aa01e7a6a7f
Inspection Facts
- Inspection number
- 1221815
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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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 |
| 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 |
| March 25, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips North America LLC
- FDA Inspection 1292226 - 2025-11-21
- FDA Inspection 1236344 - 2024-11-06
- FDA Inspection 1182153 - 2022-10-27
- FDA Inspection 1149323 - 2021-08-20
- FDA Inspection 1121760 - 2020-03-25
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