Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December
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
The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
