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934049

GlaxoSmithKline Manufacturing S.p.A. — FEI 3002807114

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Torrile (Italy)

Facility

Other inspections at this facility

  • 1244033 (VAI Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064045 (VAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982333 (NAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842545 (NAI Wed Jul 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801922 (NAI Fri Sep 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
109821 CFR 211.22(c)Approve or reject procedures or specs
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
187621 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
188321 CFR 211.165(a)Testing and release for distribution
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance