Human Genome Sciences, Inc. - September 21, 2009
Issue Date
Sep 21, 2009
Region
Central
Category
Drug
$117.00
Address 1
14200 Shady Grove Rd.
City
Rockville
State
MD
Zip/Postal Code
20850-7464
Country
US
Inspection Range
Sep 09, 2009 - Sep 21, 2009
Pages
2
First Observation
The firm failed to demonstrate the calibration range using fixed points of concentrations with accuracy. Instead, some points were outside the assay range and extrapolated.
Investigator(s): Cynthia A. Harris and John A. Kadavil