Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Sanofi’s API Facility in US Issued

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

Eudra GMDP lists Everest Organics and Ak

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend

USFDA 483 to Sun Pharma points to lack o

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by

Warning letter to Jordans Amman Pharma:

FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)

USFDA483 to Aurobindo’s Eugia US Site

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance

Warning Letter to US Eye Drop Manufactur

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at