Medefil Inc. - Feb. 2, 2024
Issue Date
Feb 02, 2024
Region
Central
Category
Drug
$117.00
Contact Name
Pradeep Aggarwal
Contact Title
CEO and President
Address 1
250 Windy Point Dr.
City
Glendale Heights
State
IL
Zip/Postal Code
60139-3805
Inspection Range
Jan 17, 2024 - Feb 02, 2024
Pages
7
First Observation
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Investigator(s): Robert J. Ham and Peng Zhou