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1236762

Nang Kuang Pharmaceutical Co., Ltd. — FEI 3004396086

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 2, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tai Nan Shi (Taiwan)

Facility

Other inspections at this facility

  • 1072749 (VAI Tue Nov 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024786 (VAI Tue Sep 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923879 (VAI Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851643 (VAI Fri Aug 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls