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1005464

Rottendorf Pharma Gmbh — FEI 3003732290

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 3, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ennigerloh (Germany)

Facility

Other inspections at this facility

  • 1303578 (VAI Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247046 (VAI Thu May 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083771 (VAI Thu Feb 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875352 (NAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779560 (VAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance