FDA Inspection 1237598 — Hepac B.V.

Hepac B.V. — FEI 3008821373

The FDA completed an inspection of Hepac B.V. on Dec 2, 2021 in Loenen Gld. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 2, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Loenen Gld (Netherlands)

Additional Details

Mutual Recognition Agreement (MRA)