ChemPacific - March 19, 2010
Issue Date
Mar 19, 2010
Region
Central
Category
Drug
$117.00
Address 1
6200 Freeport Ctr.
City
Baltimore
State
MD
Zip/Postal Code
21224
Country
US
Inspection Range
Jan 19, 2010 - Feb 17, 2010
Pages
7
First Observation
The responsibilities and procedures applicable to the quality control unit as outlined in SOP 04113 entitled “Responsibility and Authority of the Quality Department” edition 2 effective 5/28/08 are not fully followed or are inadequate.
Investigator(s): Ernest F. Bizjak, Zi Qiang Gu, Brooke K. Higgins, Latoya Oliver-Powell, and Yanyan Qin