BioZone Laboratories - April 28, 2009
Issue Date
Apr 28, 2009
Region
Pacific
Category
Drug
$117.00
Address 1
701 Willow Pass Rd.
City
Pittsburg
State
CA
Zip/Postal Code
94565-1803
Country
US
Inspection Range
Apr 22, 2009 - Apr 28, 2009
Pages
2
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): Rochelle B. Young