Discussion forum for Pharma Quality events, Regulatory Actions

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

Biocon Malaysia USFDA 483 Cites Inadequa

Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,

Qvents
August 16, 2023

IPCA USFDA 483 Highlight Criticality of

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
May 27, 2023

Environmental Monitoring Failures, Steri

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

Qvents
May 22, 2023