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911459

Gland Chemicals Private Limited — FEI 3008386908

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 4, 2015
Fiscal Year
2015
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))
  • 858417 (OAI Tue Dec 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802768 (OAI Wed Oct 10 2012 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
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
178721 CFR 211.80(a)Procedures To Be in Writing
240521 CFR 211.194(a)(7)Identification of Person Performing the Testing
440221 CFR 211.192Written record of investigation incomplete