Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA 483 to DRL : Issues in Analytical Va

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate

Qvents
June 24, 2024

Lapses in Process Validations: Torrent U

An USFDA 483 (2019) to Torrent cites deficient Process validation practices and procedures. The observations

Qvents
April 11, 2023