Jerome Stevens Pharmaceuticals, Inc. - April 4, 2013
Issue Date
Apr 04, 2013
Region
Northeast
Category
Drug
$117.00
Address 1
60 Davinci Dr.
City
Bohemia
State
NY
Zip/Postal Code
11716-2633
Country
US
Inspection Range
Mar 13, 2013 - Apr 04, 2013
Pages
1
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Robert C. Steyert