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The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April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

USFDA Implements ICH Q9(R1)

USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision

Qvents
May 22, 2023