Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Approves New Drug for Pneumonia

FDA has approved Xacduro injection (Durlobactam, a new molecular entity in combination with sulbactam) for

Environmental Monitoring Failures, Steri

In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd

USFDA Implements ICH Q9(R1)

USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision

USFDA 483 to IPCA, Silvassa Cites Lapses

FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at