FDA Inspection 1276827 — GH Genhelix S.A.

GH Genhelix S.A. — FEI 3016809519

The FDA completed an inspection of GH Genhelix S.A. on October 26, 2022 in Leon. 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
October 26, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Leon (Spain)

Additional Details

Mutual Recognition Agreement (MRA)