Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical
The Indian drug regulator, CDSCO, has published a list of spurious drugs detected in November
Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is
