FDA Inspection 1004177 — Transcoject GmbH

Transcoject GmbH — FEI 3002655329

The FDA completed an inspection of Transcoject GmbH on March 9, 2017 in Neumunster. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Neumunster (Germany)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures