06:16 PM, 17th Mar 2023
The USFDA conducted Pre-Approval Inspection [PAI] of our Oral-Oncology manufacturing facility at Bileshwarpura Gujarat from 13-Mar-23 to 17-Mar-23.At the end of the inspection we have been issued a Form 483 with 1 observation which is procedural in nature. We will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observation at the earliest.