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1273711

NATCO Pharma Limited — FEI 3004540906

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 19, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rangareddy (India)

Facility

Other inspections at this facility

  • 1137171 (VAI Mon Jun 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095772 (VAI Thu Jun 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011854 (VAI Tue Jan 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880454 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 762119 (NAI Fri Nov 18 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
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures