Svar Life Science AB — FDA Facility Profile
Svar Life Science AB is an FDA-registered facility (FEI 3007610287) located in MALMO Skane, SE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Apr 26, 2018: No Action Indicated (NAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Jan 19, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 20, 2017
- Recalls as the recalling firm
- 5, latest May 22, 2017
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 26, 2018 | No Action Indicated (NAI) | No citations listed |
| Jan 19, 2017 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design review - Lack of or inadequate procedures (21 CFR 820.30(e)) Design verification - Lack of or inadequate procedures (21 CFR 820.30(f)) Documentation (21 CFR 820.100(b)) and 3 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 22, 2017 | Not yet classified | Z-2627-2017 | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear… FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the… |
| Feb 14, 2017 | Not yet classified | Z-0306-2018 | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA
DIASTAT ANA (anti-nuclear… Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform… |
| Oct 21, 2016 | Not yet classified | Z-2919-2018 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection… and 3 more products Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Feb 14, 2016 | Not yet classified | Z-2918-2018 | Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative… Decreasing performance overtime. |
| Oct 15, 2015 | Not yet classified | Z-0929-2018 | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number… Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release… |
Facility details
- Company
- Svar Life Science AB
- Location
- MALMO Skane (SE)
- Source
- device