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1092553

LTS Lohmann Therapy Systems Corp — FEI 1000121692

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 11, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Caldwell, NJ (United States)

Facility

Other inspections at this facility

  • 1231383 (NAI Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039204 (NAI Thu Dec 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017795 (VAI Thu Jul 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982332 (VAI Mon Jul 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949822 (NAI Mon Dec 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures