Home / Inspections / 1081668

1081668

Astellas Pharma Inc. — FEI 3002807001

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 5, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Takaoka (Japan)

Facility

Other inspections at this facility

  • 1274944 (VAI Fri Jun 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963371 (NAI Fri Mar 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874760 (VAI Fri Apr 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756552 (VAI Mon Nov 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 548559 (VAI Fri Nov 07 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products