Discussion forum for Pharma Quality events, Regulatory Actions

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

Dabur Facility Placed Under Import Alert

The USFDA has placed Dabur’s Dadra and Nager Haveli facility under Import Alert 66-40 in

Qvents
June 15, 2026

Hetero USFDA Form 483: Unregistered Test

The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September

Qvents
October 18, 2025

Janssen Vaccine Unit Warning Letter Flag

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA

Qvents
October 2, 2025