Sarepta Therapeutics, Inc. - April 12, 2018
Issue Date
Apr 12, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Shamim Ruff
Contact Title
Senior Vice President Chief Regulatory Officer
Address 1
215 First St.
City
Cambridge
State
MA
Zip/Postal Code
02142-1213
Country
United States
Inspection Range
Apr 09, 2018 - Apr 12, 2018
Pages
2
First Observation
You submitted a periodic report that failed to contain an ICSR for a serious, expected, or nonserious adverse drug experience.
Investigator(s): Kent A. Conforti