Tyrone McCall - Sept. 19, 2022
Issue Date
Sep 19, 2022
Region
Southwest
Category
Clinical
$117.00
Address 1
10740 N. Central Expy.
Address 2
Ste. 350, Cornea Associates of Texas
City
Dallas
State
TX
Zip/Postal Code
75231-2163
Inspection Range
Sep 12, 2022 - Sep 19, 2022
Pages
2
First Observation
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.