FDA Inspection
Philips North America, LLCPhilips North America, LLC – FDA Inspection, Mar 10, 2009
Record Details
This FDA Inspection record concerns Philips North America, LLC, with an inspection on March 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips North America, LLC
- Inspection Date
- March 10, 2009
- Product Type
- Devices
View Company Profile
ID · de9ee8ca-f41d-432c-bb13-46b2d7ab66e6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 569821
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.184(d)Acceptance records
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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 | |
| June 18, 2015 | 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 932660 - 2015-06-18
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