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1092166

Sentiss Pharma Private Ltd. — FEI 3008250236

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 14, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
District Solan (India)

Facility

Other inspections at this facility

  • 1015447 (OAI Tue May 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890528 (OAI Tue Jul 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828511 (OAI Wed Apr 03 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
142121 CFR 211.42(c)(10)Aseptic Processing Area
145121 CFR 211.113(b)Procedures for sterile drug products
431721 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
435521 CFR 211.165(c)Sampling and testing plans not followed