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1032020

Macleods Pharmaceuticals Limited — FEI 3007517881

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 24, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tehsil Baddi, District Solan (India)

Facility

Other inspections at this facility

  • 1220834 (VAI Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1157334 (OAI Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926324 (VAI Fri May 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833839 (NAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701340 (VAI Fri Dec 10 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
136121 CFR 211.100(a)Absence of Written Procedures
180221 CFR 211.84(b)Representative Samples
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products