FDA Inspection 1152873 — Sartorius Stedim Biooutsource Limited

Sartorius Stedim Biooutsource Limited — FEI 3010165457

The FDA completed an inspection of Sartorius Stedim Biooutsource Limited on December 11, 2019 in Glasgow. 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
December 11, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glasgow (United Kingdom)

Additional Details

Mutual Recognition Agreement (MRA)