Warning letters, 483s, Recalls, Import Alerts, Audit observations
In November 2025, the USFDA issued a Warning Letter to Bangalore-based Cdymax India following an
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
Granules India received a warning letter from the USFDA in February 2025. This was along
Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in
FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning
Five different facilities of Eugia across India and US were inspected by USFDA between December
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
