F. Hoffmann-La Roche, Ltd. - May 4, 2018
Issue Date
May 04, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Anita Maurhofer
Contact Title
Site Head Kaiseraugst
Address 1
Wurmisweg
City
Kaiseraugst
Zip/Postal Code
4303
Country
Switzerland
Inspection Range
Apr 26, 2018 - May 04, 2018
Pages
3
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Michael E. Maselli and Anita Narula