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967376

Simtra Deutschland GmbH — FEI 3002806419

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 18, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halle (Westf.) (Germany)

Facility

Other inspections at this facility

  • 1283802 (OAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206312 (NAI Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161093 (VAI Wed Jan 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106642 (NAI Tue Sep 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056958 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116321 CFR 211.28(b)Habits of good sanitation & health
117421 CFR 211.42(b)Product flow through building is inadequate
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
354721 CFR 211.46(b)Equipment for Environmental Control
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete