KBI Biopharma, Inc. - March 6, 2020
Issue Date
Mar 06, 2020
Region
Southwest
Category
Drug
$117.00
Contact Name
Doris A. Micbor
Contact Title
Executive Vice President
Address 1
2500 Central Ave.
City
Boulder
State
CO
Zip/Postal Code
80301
Country
United States
Inspection Range
Mar 02, 2020 - Mar 06, 2020
Pages
1
First Observation
The characterization study performed ... did not meet the system suitability criteria ... therefore invalidating the final quality control analytical results.
Investigator(s): Erika V. Butler and Genoula K. Ryan