Discussion forum for Pharma Quality events, Regulatory Actions

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

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations

Qvents Team
June 2, 2024

FDA Untitled letter to Novartis: Signifi

FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,

Qvents
December 6, 2023

USFDA Untitled Letter To Nectar Cites De

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies

Qvents
October 23, 2023