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1092347

Hetero Labs Limited - Unit III — FEI 3005406526

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hyderabad (India)

Facility

Other inspections at this facility

  • 1210507 (VAI Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045339 (NAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993030 (VAI Wed Oct 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940470 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852628 (VAI Fri Oct 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202721 CFR 211.192Investigations of discrepancies, failures
203421 CFR 211.194(d)Laboratory equipment calibration records
362921 CFR 211.170(b)Reserve samples identified, representative, stored
363221 CFR 211.170(b)Annual visual exams of drug products