Warning letters, 483s, Recalls, Import Alerts, Audit observations
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
Merck in a statement announced that FDA’s advisory committee voted 12-1 that Gefapixant do not
USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA
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
