Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Centaur / July 2023 / C

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

VenkiOutlook
August 3, 2025

Biocon’s Biosimilar insulin Aspart rec

In a company announcement, Biocon informed that it has received a CR (Complete response) letter

Qvents
October 17, 2023