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1258820

Resilience US, Inc. — FEI 3006316363

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 21, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Chester, OH (United States)

Facility

Other inspections at this facility

  • 1099149 (NAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1043914 (VAI Thu Mar 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028106 (NAI Thu Sep 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018002 (NAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983420 (NAI Wed Aug 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
432021 CFR 211.84(d)(6)Microbiological Contamination Exam