Home / Inspections / 1024786

1024786

Nang Kuang Pharmaceutical Co., Ltd. — FEI 3004396086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 5, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tai Nan Shi (Taiwan)

Facility

Other inspections at this facility

  • 1236762 (OAI Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072749 (VAI Tue Nov 06 2018 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
111121 CFR 211.25(a)Training , Education , Experience overall
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
189021 CFR 211.165(e)Test methods
240121 CFR 211.194(a)(4)Complete Test Data
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs