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1261713

Sitec Labs Limited — FEI 3008763840

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 20, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Navi Mumbai (India)

Facility

Other inspections at this facility

  • 1242902 (VAI Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1234673 (VAI Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1191715 (NAI Fri Nov 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114219 (NAI Wed Nov 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1110281 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
440221 CFR 211.192Written record of investigation incomplete