FDA Inspection
Edwards Lifesciences, LLCEdwards Lifesciences, LLC – FDA Inspection, Sep 16, 2009
Record Details
This FDA Inspection record concerns Edwards Lifesciences, LLC, with an inspection on September 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edwards Lifesciences, LLC
- Inspection Date
- September 16, 2009
- Product Type
- Devices
View Company Profile
ID · 0c2e963f-dd3a-4dba-88af-5baced11435e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 611744
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
Other FDA inspections of Edwards Lifesciences, LLC
20| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2024 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 6, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2019 | Not classified | Los Angeles District Office | |
| August 19, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Edwards Lifesciences, LLC
- FDA Inspection 1229680 - 2024-08-15
- FDA Inspection 1194166 - 2022-12-06
- FDA Inspection 1102311 - 2019-08-29
- FDA Inspection 1100450 - 2019-08-19
- FDA Inspection 1093187 - 2019-06-14
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