FDA Inspection 1322002 — Particle Analytical ApS

Particle Analytical ApS — FEI 3007704654

The FDA completed an inspection of Particle Analytical ApS on January 9, 2025 in Horsholm. 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
January 9, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Horsholm (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)