FDA Inspection 1158367 — piCHEM Forschungs-und Entwicklungs GmbH

piCHEM Forschungs-und Entwicklungs GmbH — FEI 3003780817

The FDA completed an inspection of piCHEM Forschungs-und Entwicklungs GmbH on February 3, 2021 in Raaba-Grambach. 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
February 3, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Raaba-Grambach (Austria)

Additional Details

Mutual Recognition Agreement (MRA)