FDA Inspection 1319882 — Elementis Pharma GmbH

Elementis Pharma GmbH — FEI 3002807069

The FDA completed an inspection of Elementis Pharma GmbH on November 29, 2023 in Ludwigshafen Am Rhein. 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
November 29, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ludwigshafen Am Rhein (Germany)

Additional Details

Mutual Recognition Agreement (MRA)