FDA Inspection
Edwards Lifesciences, LLCEdwards Lifesciences, LLC – FDA Inspection, Nov 4, 2009
Record Details
This FDA Inspection record concerns Edwards Lifesciences, LLC, with an inspection on November 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edwards Lifesciences, LLC
- Inspection Date
- November 4, 2009
- Product Type
- Devices
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ID · a59e6923-a791-4f38-980a-265f4a64e9be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 627356
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
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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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