Discussion forum for Pharma Quality events, Regulatory Actions

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

Biocon Malaysia inspection classified OA

In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI

Qvents
October 19, 2023

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