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1102938

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 26, 2019
Fiscal Year
2019
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))
  • 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))
  • 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
145121 CFR 211.113(b)Procedures for sterile drug products
184921 CFR 211.84(d)(6)Objectionable microbiological contamination
203121 CFR 211.194(a)Complete test data included in records
358221 CFR 211.105(a)Identification of containers, lines, equipment
438921 CFR 211.198(a)Procedures to be written and followed