FDA Inspection
Edwards Lifesciences Technology SARLEdwards Lifesciences Technology SARL – FDA Inspection, Jan 27, 2015
Record Details
This FDA Inspection record concerns Edwards Lifesciences Technology SARL, with an inspection on January 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 27, 2015
- Product Type
- Devices
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ID · aff2bac2-a878-4c60-b6fb-fbd8eb4f456c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911643
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Edwards Lifesciences Technology SARL
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2017 | Not classified | San Juan District Office | |
| April 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Edwards Lifesciences Technology SARL
- FDA Inspection 1093287 - 2019-06-11
- FDA Inspection 1018411 - 2017-03-24
- FDA Inspection 657755 - 2010-04-15
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