Biogen, Inc. - April 6, 2017
Issue Date
Apr 06, 2017
Region
Northeast
Category
Drug
$117.00
Contact Name
Sherry L. Smith
Contact Title
Director R&D Quality and Compliance
Address 1
300 Binney St.
City
Cambridge
State
MA
Zip/Postal Code
02142
Country
United States
Inspection Range
Mar 27, 2017 - Apr 06, 2017
Pages
4
First Observation
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Investigator(s): Richard A. Abate, Erik W. Koester, and John P. Mistler