AUGUST REUCHLEN GMBH — FDA Facility Profile
AUGUST REUCHLEN GMBH is an FDA-registered facility (FEI 4439) located in TUTTLINGEN Baden-Wurttemberg, DE. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 VAI, 1 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
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | Voluntary Action Indicated (VAI) | Supplier oversight (21 CFR 820.50(a)(2)) Documentation (21 CFR 820.100(b)) |
| Jul 2, 2015 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Documentation of validated process performance (21 CFR 820.75(b)(2)) Documentation (21 CFR 820.100(b)) Document review, approval by designated individual (21 CFR 820.40(a)) |
Form 483s and inspection documents
Facility details
- Company
- August Reuchlen GmbH
- Location
- TUTTLINGEN Baden-Wurttemberg (DE)
- Source
- device