VOCO GMBH FDA Inspection Record
VOCO GMBH is an FDA-registered facility (FEI 3002718942) located in CUXHAVEN Lower Saxony, DE. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Jun 20, 2013: No Action Indicated (NAI)
- Inspections on record
- 1 (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
- Recalls as the recalling firm
- 3, latest Jan 25, 2024
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 20, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jan 25, 2024 | Class II | Z-1142-2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f)… and 1 more product Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does… |
| Jul 9, 2019 | Class II | Z-0028-2020 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities… The metal cannula are potentially too loose and may become loose when applying the filing material. |
| Nov 3, 2016 | Class II | Z-0955-2017 | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental… Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. |
Facility details
- Company
- Voco GmbH
- Location
- CUXHAVEN Lower Saxony (DE)
- Source
- device