Home / Inspections / 1195842

1195842

Baxter Pharmaceuticals India Pvt Ltd — FEI 3004610460

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 27, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ahmedabad (India)

Facility

Other inspections at this facility

  • 1169631 (VAI Tue May 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028732 (OAI Fri Aug 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986348 (VAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929802 (VAI Mon May 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853758 (VAI Fri Oct 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
200821 CFR 211.186(a)Written procedures followed
201721 CFR 211.188(b)(5)In-Process and Laboratory Control Results
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls