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1120136

Jubilant Cadista Pharmaceuticals — FEI 3017221809

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 28, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yardley, PA (United States)

Facility

Other inspections at this facility

  • 1257696 (VAI Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064090 (NAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940733 (VAI Fri Aug 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888209 (NAI Tue Jul 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842669 (NAI Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145021 CFR 211.113(a)Procedures for non-sterile drug products
2153621 CFR 514.80(b)(1)Applicant did not submit/submitted late 3-Day Field Alert Report or wrong format
438921 CFR 211.198(a)Procedures to be written and followed