CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG FDA Inspection Record
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG is an FDA-registered facility (FEI 3003081151) located in HAINA San Cristobal, DO. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Dec 9, 2015: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 7
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 9, 2015 | Voluntary Action Indicated (VAI) | Software validation for automated processes (21 CFR 820.70(i)) Investigation of device failures (21 CFR 820.198(c)) |
Facility details
- Company
- CCT Critical Care Technologies, S.R.L.
- Location
- HAINA San Cristobal (DO)
- Source
- device