EUROAPI Hungary Ltd. — FDA Facility Profile
EUROAPI Hungary Ltd. is an FDA-registered facility (FEI 3002806675) located in Hungary (HUN). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; PACK. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 21, 2019: No Action Indicated (NAI)
- Inspections on record
- 5 (2 VAI, 3 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
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 21, 2019 | No Action Indicated (NAI) | No citations listed |
| Apr 20, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 3, 2017 | Voluntary Action Indicated (VAI) | Complete test data included in records (21 CFR 211.194(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Calculations performed are in the records (21 CFR 211.194(a)(5)) |
| May 30, 2014 | No Action Indicated (NAI) | No citations listed |
| Feb 4, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- EuroAPI Hungary Ltd.
- Location
- Hungary (HUN)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; PACK
- Source
- decrs