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1222556

Dr. Reddy's Laboratories Ltd. — FEI 3002949099

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 27, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Medchal-Malkajgiri District (India)

Facility

Other inspections at this facility

  • 1121029 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079024 (VAI Fri Feb 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010046 (VAI Fri Apr 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940784 (VAI Wed Jun 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836270 (NAI Thu Apr 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
356521 CFR 211.58Buildings not maintained in good state of repair
361121 CFR 211.160(b)(3)Acceptance of drug products
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs