Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Pharmathen Flags Deficient

USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form

Sun Pharma Baska Facility Classified OAI

The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated

USFDA Warning Letter to Catalent Indiana

The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent

Cipla Warning letter cites gaps in Compl

The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore

Warning Letter to US Eye Drop Manufactur

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