FAREVA Unterach GmbH — FDA Facility Profile
FAREVA Unterach GmbH is an FDA-registered facility (FEI 3002829723) located in Unterach am Attersee, AT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jun 2, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (1 OAI, 5 VAI, 1 NAI)
- Last OAI inspection
- Oct 23, 2012
- Warning letters
- 1 listed by FDA for this FEI, latest May 28, 2013
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 2, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 10, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| May 8, 2019 | Voluntary Action Indicated (VAI) | Written program not followed (21 CFR 211.166(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) |
| Dec 18, 2014 | No Action Indicated (NAI) | No citations listed |
| Oct 23, 2012 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Equipment Design, Size and Location (21 CFR 211.63) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) SOPs not followed / documented (21 CFR 211.100(b)) and 4 more |
| Jul 25, 2011 | Voluntary Action Indicated (VAI) | Product flow through building is inadequate (21 CFR 211.42(b)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Cleaning System (21 CFR 211.42(c)(10)(v)) and 7 more |
| Mar 12, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Fareva Unterach GmbH
- Location
- Unterach am Attersee (AT)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE
- Source
- decrs