Home / Inspections / 1018720

1018720

Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) — FEI 3004810446

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vapi (India)

Facility

Other inspections at this facility

  • 1231931 (VAI Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065141 (NAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 957768 (VAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878346 (VAI Thu Apr 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 684841 (VAI Thu Sep 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
367721 CFR 820.30(g)Design validation - software validation not performed
430221 CFR 211.56(b)Written sanitation procedures not followed
434221 CFR 211.142(b)Storage under appropriate conditions