Eosera, Inc. - Jan. 17, 2020
Issue Date
Jan 17, 2020
Region
Southwest
Category
Drug
$117.00
Contact Name
Elyse Dickerson
Contact Title
CEO
Address 1
5000 South Fwy.
Address 2
Ste. 106
City
Fort Worth
State
TX
Zip/Postal Code
76115-3902
Country
United States
Inspection Range
Jan 13, 2020 - Jan 17, 2020
Pages
3
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Patty Kaewussdangkul and Shanna N. Purdy