VitalScientific — FDA Facility Profile
VitalScientific is an FDA-registered facility (FEI 3007662974) located in SEES Normandie, FR. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Sep 5, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (1 VAI, 2 NAI)
- 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
- Recalls as the recalling firm
- 4, latest Apr 18, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 5, 2024 | Voluntary Action Indicated (VAI) | Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) |
| Mar 30, 2017 | No Action Indicated (NAI) | No citations listed |
| Nov 20, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 18, 2017 | Class II | Z-2591-2018 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level… ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500… |
| Sep 22, 2015 | Class II | Z-0214-2016 | Eon 100 system included the following product reference numbers and names:
Reference… and 3 more products ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug… |
| Aug 11, 2014 | Class III | Z-0006-2015 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500.
Intended… Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the… |
| Sep 4, 2013 | Class II | Z-0178-2014 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human… Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. |
Facility details
- Company
- VitalScientific
- Location
- SEES Normandie (FR)
- Source
- device