FDA Inspection 1287750 — 5N Plus Lubeck GmbH

5N Plus Lubeck GmbH — FEI 3002807159

The FDA completed an inspection of 5N Plus Lubeck GmbH on April 27, 2023 in Lubeck. 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
April 27, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lubeck (Germany)

Additional Details

Mutual Recognition Agreement (MRA)