Jerome Stevens Pharmaceuticals, Inc. - Nov. 22, 2011
Issue Date
Nov 22, 2011
Region
Northeast
Category
Drug
$117.00
Address 1
60 Davinci Dr.
City
Bohemia
State
NY
Zip/Postal Code
11716-2633
Country
US
Inspection Range
Nov 07, 2011 - Nov 22, 2011
Pages
5
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): Alice S. Tsao