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802768

Gland Chemicals Private Limited — FEI 3008386908

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 10, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chennai (India)

Facility

Other inspections at this facility

  • 1297216 (OAI Thu Nov 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050982 (OAI Tue Apr 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911459 (VAI Wed Feb 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858417 (OAI Tue Dec 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 719740 (NAI Wed Mar 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116321 CFR 211.28(b)Habits of good sanitation & health
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
356521 CFR 211.58Buildings not maintained in good state of repair
430621 CFR 211.80(a)Written Procedures Not Followed