FDA Inspection
Philips North America LLCPhilips North America LLC – FDA Inspection, Oct 27, 2022
Record Details
This FDA Inspection record concerns Philips North America LLC, with an inspection on October 27, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America LLC
- Inspection Date
- October 27, 2022
- Product Type
- Devices
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ID · c3c38841-45c1-4d4e-bacd-8cb043014c7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182153
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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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 | |
| 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 1221815 - 2023-11-03
- FDA Inspection 1149323 - 2021-08-20
- FDA Inspection 1121760 - 2020-03-25
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