FDA Inspection 1035009 — Charles River Laboratories Germany GmbH

Charles River Laboratories Germany GmbH — FEI 3004512725

The FDA completed an inspection of Charles River Laboratories Germany GmbH on December 15, 2017 in Erkrath. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Erkrath (Germany)

Citations

IDCFRDescription
197521 CFR 211.182Written records kept in individual logs