APP Pharmaceuticals, LLC - October 29, 2010
Issue Date
Oct 29, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
8900 Capital Blvd.
City
Raleigh
State
NC
Zip/Postal Code
27616-3117
Country
US
Inspection Range
Oct 25, 2010 - Oct 29, 2010
Pages
2
First Observation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Hai Lien T. Phung and Esra Toussaint