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1118070

Rommelag CDMO GmbH — FEI 3002808845

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 18, 2020
Fiscal Year
2020
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Sulzbach-Laufen (Germany)

Facility

Other inspections at this facility

  • 1198954 (NAI Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107432 (NAI Tue Sep 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949464 (VAI Thu Oct 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880428 (VAI Fri Feb 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880920 (VAI Wed Feb 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145221 CFR 211.113(b)Validation lacking for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls