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1028353

Lotus Pharmaceutical Co., Ltd. — FEI 3005999589

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 22, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nan Tou Xian (Taiwan)

Facility

Other inspections at this facility

  • 1236763 (VAI Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095930 (NAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933276 (VAI Thu Jun 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797095 (NAI Thu Aug 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 655757 (VAI Thu Feb 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
363221 CFR 211.170(b)Annual visual exams of drug products
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly