Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Glenmark Pithampur Facility Issued USFDA

USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The

Yiling Pharma Warning Letter: Equipment

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025

Sanofi’s API Facility in US Issued

The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,

FDA Warning letter to Natco over Cleanin

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following

Environmental Monitoring Failures, Steri

In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd