Biogen, lnc. - June 16, 2021
Issue Date
Jun 16, 2021
Region
Southeast
Category
Drug
$117.00
Contact Name
Melissa Seymour
Contact Title
Head of Global Quality & Chief Quality Officer
Address 1
5000 Davis Dr.
City
Research Triangle Park
State
NC
Zip/Postal Code
27709
Country
United States
Inspection Range
Jun 07, 2021 - Jun 16, 2021
Pages
5
First Observation
There is inadequate documentation for training sample set in … and lack of traceability for samples used for QC lab analyst training.
Investigator(s): Wayne Seifert and Zhao Wang