FDA Inspection
Edwards Lifesciences, LLCEdwards Lifesciences, LLC – FDA Inspection, Feb 22, 2013
Record Details
This FDA Inspection record concerns Edwards Lifesciences, LLC, with an inspection on February 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edwards Lifesciences, LLC
- Inspection Date
- February 22, 2013
- Product Type
- Devices
View Company Profile
ID · 7673b1e8-e43c-40f2-b9c5-1770f11fcc90
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 819579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Edwards Lifesciences, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 29, 2017 | Not classified | Denver District Office | |
| May 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Edwards Lifesciences, LLC
- FDA Inspection 1159431 - 2021-11-19
- FDA Inspection 1041783 - 2018-02-01
- FDA Inspection 1042659 - 2017-09-29
- FDA Inspection 973557 - 2016-05-20
- FDA Inspection 951141 - 2015-11-20
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