Jerome Stevens Pharmaceuticals, Inc. - April 11, 2019
Issue Date
Apr 11, 2019
Region
Northeast
Category
Drug
$117.00
Contact Name
Daniel R. Akeson
Contact Title
Director
Address 1
60 Davinci Dr.
City
Bohemia
State
NY
Zip/Postal Code
11716-2633
Country
United States
Inspection Range
Apr 08, 2019 - Apr 11, 2019
Pages
3
First Observation
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
Investigator(s): Karen L. Kosar and Omadevi Somai