MEDART ApS — FDA Facility Profile
MEDART ApS is an FDA-registered facility (FEI 3005616124) located in HVIDOVRE Hovedstaden, DK. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 24, 2015: No Action Indicated (NAI)
- Inspections on record
- 3 (1 OAI, 1 VAI, 1 NAI)
- Last OAI inspection
- Jun 1, 2012
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 19, 2012
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 24, 2015 | No Action Indicated (NAI) | No citations listed |
| Sep 13, 2013 | Voluntary Action Indicated (VAI) | Design review procedures - personnel (21 CFR 820.30(e)) Supplier notification of changes (21 CFR 820.50(b)) Aperture label - laser radiation (21 CFR 1040.10(g)(5)(i)) Failure to submit, distinct marking (21 CFR 1002.10) and 1 more |
| Jun 1, 2012 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Design plans - Lack of or inadequate (21 CFR 820.30(b)) Design review - Lack of or inadequate procedures (21 CFR 820.30(e)) and 8 more |
Facility details
- Company
- Medart A /S
- Location
- HVIDOVRE Hovedstaden (DK)
- Source
- device