Sentio BioSciences, LLC - May 19, 2017
Issue Date
May 19, 2017
Region
Southwest
Category
Device
$117.00
Contact Name
Karthik Raghavan
Contact Title
President and CEO
Address 1
218 B Millwell Dr.
City
Maryland Heights
State
MO
Zip/Postal Code
63043
Country
United States
Inspection Range
Apr 24, 2017 - May 19, 2017
Pages
8
First Observation
Control procedures are not established or followed which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug substance.
Investigator(s): Kellia N. Hicks