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828922

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 25, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
162621 CFR 211.130Procedures are written, and followed
200921 CFR 211.188Prepared for each batch, include complete information
358521 CFR 211.110(a)Control procedures to monitor and validate performance
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications