ALBER GMBH — FDA Facility Profile
ALBER GMBH is an FDA-registered facility (FEI 3004730072) located in ALBSTADT Baden-Wurttemberg, DE. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Dec 15, 2022: No Action Indicated (NAI)
- Inspections on record
- 4 (1 OAI, 1 VAI, 2 NAI)
- Last OAI inspection
- May 11, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 15, 2017
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 15, 2022 | No Action Indicated (NAI) | No citations listed |
| Apr 12, 2018 | No Action Indicated (NAI) | No citations listed |
| May 11, 2017 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Aug 28, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Alber GmbH
- Location
- ALBSTADT Baden-Wurttemberg (DE)
- Source
- device