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FDA Inspection 1086614 — Sartorius Stedim Biooutsource Limited

Sartorius Stedim Biooutsource Limited — FEI 3010165457

The FDA completed an inspection of Sartorius Stedim Biooutsource Limited on March 6, 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Glasgow (United Kingdom)

Facility

Other inspections at this facility

  • 1285976 (NAI Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152873 (VAI Wed Dec 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029992 (NAI Wed Sep 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956573 (NAI Tue Jan 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources