Discussion forum for Pharma Quality events, Regulatory Actions

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

OAI Classification for Sun Pharma Halol

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official

Qvents Team
September 11, 2025

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical

Qvents
February 26, 2025

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