Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality)
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
Health Ministry in India has extended the timeline for implementation of the revised Schedule M
