Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
