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1050982

Gland Chemicals Private Limited — FEI 3008386908

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 3, 2018
Fiscal Year
2018
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))
  • 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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
145121 CFR 211.113(b)Procedures for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440221 CFR 211.192Written record of investigation incomplete
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications