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1043371

Gland Pharma Limited — FEI 3009864167

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 23, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sangareddy district, Hyderabad (India)

Facility

Other inspections at this facility

  • 1216053 (VAI Sat Aug 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210478 (VAI Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109239 (VAI Thu Nov 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944183 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
145121 CFR 211.113(b)Procedures for sterile drug products
2129521 CFR 211.110(b)In-process conformity - examination, sample testing
241921 CFR 211.198(a)Complaint Handling Procedure