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

FDA Classifies Novo Nordisk Plant OAI, P

Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in

Qvents
October 31, 2025

FDA 483 to Catalent Indiana Flags Inadeq

Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June

Qvents
August 25, 2025