Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Medgel / July 2023 / In

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Qvents
August 23, 2023

Biocon Malaysia facility USFDA 483 ̵

Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,

Qvents
August 16, 2023

USFDA 483 / IPCA Laboratories, Silvassa,

USFDA 483 to IPCA, Silvassa (April 2023) cites inadequacies and thoroughness in Out of specification

Qvents
May 27, 2023