Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Untitled Letter To Nectar Cites De

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies

Qvents
October 23, 2023

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

Warning Letter to US Eye Drop Manufactur

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at

Qvents
August 30, 2023