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FDA Inspection 1251969 — Baxalta Belgium Manufacturing SA

Baxalta Belgium Manufacturing SA — FEI 3002806503

The FDA completed an inspection of Baxalta Belgium Manufacturing SA on November 22, 2024 in Lessines. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 22, 2024
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Lessines (Belgium)

Citations

IDCFRDescription
201421 CFR 211.188(b)(2)Identification of Equipment and Lines

Facility

Other inspections at this facility

  • 1093550 (VAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918229 (VAI Tue Feb 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841219 (NAI Tue Jun 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827427 (VAI Tue Mar 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712920 (OAI Fri Jan 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources