FDA Inspection 1312646 — Puracon GmbH

Puracon GmbH — FEI 3004638532

The FDA completed an inspection of Puracon GmbH on February 26, 2026 in Rosenheim. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 26, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Rosenheim (Germany)