Gentrac, Inc. (King Pharmaceuticals) - January 28, 2010
Issue Date
Jan 28, 2010
Region
Central
Category
Drug
$117.00
Address 1
2232 Pleasant View Rd.
City
Middleton
State
WI
Zip/Postal Code
53562
Country
US
Inspection Range
Jan 20, 2010 - Jan 28, 2010
Pages
8
First Observation
There are no assurances that the current assay test method is adequate for the determination of the reduction of Factor Va light chain content to levels below 92 ng/mL in Bulk Thrombin-JMI. The currently used "semi-quantitative Western Blot assay" has not been adequately validated per SOP-PHR-GEN-00013-MD, determination of Factor Va by Western Blot.
Investigator(s): Melissa J. Ireland, Omotunde O. Osunsanmi, and Chava Kimchi Sarfaty