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1250072

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Maricao, PR (United States)

Facility

Other inspections at this facility

  • 1180297 (OAI Sat Sep 24 2022 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
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
194221 CFR 211.180(e)Records reviewed annually
354721 CFR 211.46(b)Equipment for Environmental Control
355721 CFR 211.52Washing and toilet facilities are deficient
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls