Warning letters, 483s, Recalls, Import Alerts, Audit observations
Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small
System sensitivity requirement is limited to impurities where a reporting threshold is specified and Peak
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
A WHO-Listed Authority (WLA) is a National Regulatory Authority (NRA) that is recognised as meeting
Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy
USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due
