GenTrac, Inc. - Sept. 12, 2019
Issue Date
Sep 12, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Amy R. Pralat
Contact Title
Site Leader
Address 1
2232 Pleasant View Rd.
City
Middleton
State
WI
Zip/Postal Code
53562-5523
Country
United States
Inspection Range
Sep 04, 2019 - Sep 12, 2019
Pages
3
First Observation
Your current approved process under BLA 102865 does not allow ... of bulk
Thrombin … at any step.
Investigator(s): Debra M. Emerson, Peter Kessler, and Ze Peng