Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch
Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March
Five different facilities of Eugia across India and US were inspected by USFDA between December
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
