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1025276

LTS Lohmann Therapie-Systeme AG — FEI 3003387535

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Andernach (Germany)

Facility

Other inspections at this facility

  • 1264907 (NAI Wed May 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116639 (VAI Thu Oct 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865616 (NAI Fri Dec 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 735498 (VAI Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605480 (NAI Thu Jun 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures