Emerald Kalama Chemical, LLC - December 17, 2009
Issue Date
Dec 17, 2009
Region
Pacific
Category
Drug
$117.00
Address 1
1296 3rd St., NW
City
Kalama
State
WA
Zip/Postal Code
98625-9701
Country
US
Inspection Range
Dec 14, 2009 - Dec 17, 2009
Pages
2
First Observation
The firm lacks a complete evaluation to support the suitability, qualification and/or approval of the micron and micron filter bags used in the transfer line of the drug substance API to the drum filling station. The two filter housings containing these filters are located between storage tank and the drum filling station manifold.
Investigator(s): Cynthia J. Lee and Mikel T. Wright