Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Warning Letter to Catalent Indiana

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

Qvents
December 16, 2025

Cipla Warning letter cites gaps in Compl

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

Qvents
November 22, 2023

Warning Letter to US Eye Drop Manufactur

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

Qvents
August 30, 2023