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1220834

Macleods Pharmaceuticals Limited — FEI 3007517881

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 20, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tehsil Baddi, District Solan (India)

Facility

Other inspections at this facility

  • 1157334 (OAI Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032020 (OAI Fri Nov 24 2017 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
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
192021 CFR 211.166(a)(3)Valid stability test methods
202621 CFR 211.192Quality control unit review of records
359121 CFR 211.110(b)In-process materials specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration