Straight Arrow Products, Inc. - September 23, 2010
Issue Date
Sep 23, 2010
Region
Central
Category
Drug
$117.00
Address 1
2020 Highland Ave.
City
Bethlehem
State
PA
Zip/Postal Code
18020-8963
Country
US
Inspection Range
Sep 16, 2010 - Sep 23, 2010
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): Brandi L. Garbutt and Susan E. Polifko