Warning letters, 483s, Recalls, Import Alerts, Audit observations
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,
Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December
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
Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,
USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd
