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1283802

Simtra Deutschland GmbH — FEI 3002806419

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 26, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halle (Westf.) (Germany)

Facility

Other inspections at this facility

  • 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))
  • 1019700 (VAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
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
145221 CFR 211.113(b)Validation lacking for sterile drug products
200821 CFR 211.186(a)Written procedures followed
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls