FDA Inspection
Edwards Lifesciences Technology SARLEdwards Lifesciences Technology SARL – FDA Inspection, Jun 11, 2019
Record Details
This FDA Inspection record concerns Edwards Lifesciences Technology SARL, with an inspection on June 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e564500e-29e0-4600-87e6-c39bad3f4a6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093287
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
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Other FDA inspections of Edwards Lifesciences Technology SARL
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2017 | Not classified | San Juan District Office | |
| January 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Edwards Lifesciences Technology SARL
- FDA Inspection 1018411 - 2017-03-24
- FDA Inspection 911643 - 2015-01-27
- FDA Inspection 657755 - 2010-04-15
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