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1208260

Pharmacia & Upjohn Company LLC — FEI 1810189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Kalamazoo, MI (United States)

Facility

Other inspections at this facility

  • 1143004 (VAI Thu May 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074087 (VAI Mon Dec 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066512 (VAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036094 (NAI Fri Dec 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031063 (VAI Tue Nov 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation