Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

FDA publish the USFDA483 issued to Intas

Batch records do not include complete instructions and records Manual visual inspection records of parental