MAQUET GMBH FDA Inspection Record
MAQUET GMBH is an FDA-registered facility (FEI 1841) located in RASTATT Baden-Wurttemberg, DE. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Nov 19, 2015: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- 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
- Recalls as the recalling firm
- 1, latest Jul 14, 2025
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 19, 2015 | Voluntary Action Indicated (VAI) | Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) Investigation of device failures (21 CFR 820.198(c)) Documented evaluation (21 CFR 820.50(a)(1)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 14, 2025 | Class II | Z-2420-2025 | Corin Operating Tables
Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4)… Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF)… |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
Reviewing MAQUET GMBH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check MAQUET GMBH yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Facility details
- Company
- MAQUET GMBH
- Location
- RASTATT Baden-Wurttemberg (DE)
- Source
- device