Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA issues new draft guidance for Post

As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities

Qvents
September 3, 2023

Warning letter / Centaur / July 2023 / F

The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over

Qvents
August 7, 2023