Home / Inspections / 1152927

1152927

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2021
Fiscal Year
2021
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))
  • 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
145121 CFR 211.113(b)Procedures for sterile drug products
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete