FDA Inspection
Philips North America, LLCPhilips North America, LLC – FDA Inspection, Jun 18, 2015
Record Details
This FDA Inspection record concerns Philips North America, LLC, with an inspection on June 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America, LLC
- Inspection Date
- June 18, 2015
- Product Type
- Devices
View Company Profile
ID · 9d36fe95-670f-4894-8c09-bb9a0629541d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 932660
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Philips North America, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2019 | Not classified | New England District Office | |
| December 4, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2017 | Not classified | New England District Office | |
| December 12, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips North America, LLC
- FDA Inspection 1260630 - 2025-01-16
- FDA Inspection 1142575 - 2019-08-23
- FDA Inspection 1073570 - 2018-12-04
- FDA Inspection 1034836 - 2017-07-14
- FDA Inspection 860079 - 2013-12-12
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