AL&S - July 16, 2010
Issue Date
Jul 16, 2010
Region
Southwest
Category
Drug
$117.00
Address 1
16477 Highway 16 East
City
De Kalb
State
MS
Zip/Postal Code
39328-5508
Country
US
Inspection Range
Jul 12, 2010 - Jul 16, 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 is the characteristics of in-process material and the drug product.
Investigator(s): Zada L. Giles and Marvin D. Jones