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1026548

TAIWAN BIOTECH CO., LTD. — FEI 3003598505

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 11, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Taoyuan City (Taiwan)

Facility

Other inspections at this facility

  • 1181337 (OAI Tue Sep 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014787 (VAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885228 (VAI Fri May 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746051 (NAI Fri Aug 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
191221 CFR 211.166(a)Written program not followed
194221 CFR 211.180(e)Records reviewed annually
195621 CFR 211.180(e)(1)Representative Number of Batches for Annual Review