FDA Inspection
Philips North America LLCPhilips North America LLC – FDA Inspection, Aug 29, 2012
Record Details
This FDA Inspection record concerns Philips North America LLC, with an inspection on August 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America LLC
- Inspection Date
- August 29, 2012
- Product Type
- Devices
View Company Profile
ID · d62da4b7-87a3-4073-a906-7943704db483
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801680
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
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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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