FDA Inspection 1235327 — UNA-Synth GmbH

UNA-Synth GmbH — FEI 3010471580

The FDA completed an inspection of UNA-Synth GmbH on May 25, 2023 in Kaltenkirchen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 25, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kaltenkirchen (Germany)

Additional Details

Mutual Recognition Agreement (MRA)