AveXis, Inc. - Aug. 2, 2019
Issue Date
Aug 02, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Mark Roache
Contact Title
Senior Vice President and Chief Quality Officer
Address 1
10210 Campus Point Dr.
Address 2
Ste. 300
City
San Diego
State
CA
Zip/Postal Code
92121-1522
Country
United States
Inspection Range
Jul 24, 2019 - Aug 02, 2019
Pages
4
First Observation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Investigator(s): Scott T. Ballard and Mihaly S. Ligmond