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1238749

EUGIA Pharma Specialities Limited — FEI 3009883410

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 3, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Riico Industrial Area (India)

Facility

Other inspections at this facility

  • 1297436 (OAI Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1227549 (VAI Fri Jun 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155857 (VAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1043313 (VAI Tue Mar 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944865 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning 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