Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA issues guidance on alternative tools

In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing