FDA Inspection 1288878 — Wacker Biotech GmbH

Wacker Biotech GmbH — FEI 3008840280

The FDA completed an inspection of Wacker Biotech GmbH on December 7, 2023 in Halle (Saale). 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
December 7, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halle (Saale) (Germany)

Additional Details

Mutual Recognition Agreement (MRA)