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1180297

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Maricao, PR (United States)

Facility

Other inspections at this facility

  • 1250072 (VAI Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152927 (OAI Fri Sep 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102938 (OAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022483 (VAI Tue Aug 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920228 (NAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
360321 CFR 211.160(b)Scientifically sound laboratory controls