EMD Serono, Inc. - June 17, 2016
Issue Date
Jun 17, 2016
Region
Northeast
Category
Drug
$117.00
Contact Name
Daryl Dawson
Contact Title
Vice President and Head US Drug Safety & Quality Assurance
Address 1
1 Technology Pl.
City
Rockland
State
MA
Zip/Postal Code
02370
Country
United States
Inspection Range
May 29, 2016 - Jun 17, 2016
Pages
4
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): Erik W. Koester and John P. Mistler