American Regent, Inc. - March 8, 2019
Issue Date
Mar 08, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Eamonn M. McMahon
Contact Title
Director of Quality Assurance
Address 1
4150 Lyman Dr.
City
Hilliard
State
OH
Zip/Postal Code
43026
Country
United States
Inspection Range
Feb 26, 2019 - Mar 08, 2019
Pages
3
First Observation
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.