Home / Inspections / 1015447

1015447

Sentiss Pharma Private Ltd. — FEI 3008250236

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 23, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
District Solan (India)

Facility

Other inspections at this facility

  • 1092166 (OAI Tue May 14 2019 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
104921 CFR 211.22(a)Approve or reject components, products
111121 CFR 211.25(a)Training , Education , Experience overall
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
192021 CFR 211.166(a)(3)Valid stability test methods
202821 CFR 211.192Extent of discrepancy, failure investigations
203121 CFR 211.194(a)Complete test data included in records
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360321 CFR 211.160(b)Scientifically sound laboratory controls