Home / Inspections / 1090548

1090548

Gland Pharma Limited — FEI 3002647489

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 16, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hyderabad (India)

Facility

Other inspections at this facility

  • 1244548 (VAI Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210381 (VAI Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179407 (VAI Thu Aug 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002974 (VAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921536 (VAI Tue Mar 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117421 CFR 211.42(b)Product flow through building is inadequate
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
440221 CFR 211.192Written record of investigation incomplete