EUROTROL B.V. — FDA Facility Profile
EUROTROL B.V. is an FDA-registered facility (FEI 3005695774) located in EDE Gelderland, NL. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 6, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- May 22, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 19, 2014
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 6, 2016 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design verification - output does not meet input requirement (21 CFR 820.30(f)) Lack of or inadequate procedures (21 CFR 820.100(a)) Maintenance schedule, Lack of or inadequate schedule (21 CFR 820.70(g)(1)) and 3 more |
| May 22, 2014 | Official Action Indicated (OAI) | No citations listed |
Facility details
- Company
- Eurotrol B.V.
- Location
- EDE Gelderland (NL)
- Source
- device