Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September
The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP
USFDA Warning letter to Glenmark Facility at Pithampur (FEI 3008565058), cited cGMP violations at multiple
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning
Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India
Authored by: Srinivas Churya In the pharmaceutical industry, analytical division and analytical laboratories plays a
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
