Home / Inspections / 1091278

1091278

OrBion Pharmaceuticals Private Limited — FEI 3004540907

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chennai (India)

Facility

Other inspections at this facility

  • 1217144 (VAI Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934390 (VAI Wed Jun 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841047 (NAI Fri Jun 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732080 (VAI Thu Apr 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145021 CFR 211.113(a)Procedures for non-sterile drug products
189021 CFR 211.165(e)Test methods
354721 CFR 211.46(b)Equipment for Environmental Control
358621 CFR 211.110(a)(1)Tablet or capsule weight variation
360321 CFR 211.160(b)Scientifically sound laboratory controls