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1261312

Genzyme Corporation — FEI 3009389940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Northborough, MA (United States)

Facility

Other inspections at this facility

  • 1281578 (NAI Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120993 (NAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062695 (NAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985381 (VAI Thu Aug 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896910 (NAI Thu Sep 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
162621 CFR 211.130Procedures are written, and followed
163321 CFR 211.130(d)Examination of packaging and labeling
457621 CFR 211.192No written record of investigation