Frontida BioPharm, Inc. - Dec. 7, 2023
Issue Date
Dec 07, 2023
Region
Central
Category
Drug
$117.00
Contact Name
Joseph D. Jefferson
Contact Title
Sr. Director, Manufacturing Operations & Site Head
Address 1
1100 Orthodox St.
City
Philadelphia
State
PA
Zip/Postal Code
19124-3168
Inspection Range
Nov 28, 2023 - Dec 07, 2023
Pages
4
First Observation
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
Investigator(s): Anastasia M. Shields