FDA Inspection 1068935 — Alk-abello A/s

Alk-abello A/s — FEI 3002806343

The FDA completed an inspection of Alk-abello A/s on September 17, 2018 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 17, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Horsholm (Denmark)