Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Issues Guidance for Impurity Speci

The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April

Qvents
April 21, 2026

Responding to FDA Form 483: USFDA Issues

The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at

Qvents
April 2, 2026