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890528

Sentiss Pharma Private Ltd. — FEI 3008250236

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 29, 2014
Fiscal Year
2014
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))
  • 1015447 (OAI Tue May 23 2017 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
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
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
203121 CFR 211.194(a)Complete test data included in records