Discussion forum for Pharma Quality events, Regulatory Actions

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

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

Qvents
June 10, 2024

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

Qvents
October 30, 2023

Warning letter / Medgel / July 2023 /Lap

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Qvents
August 23, 2023

USFDA 483 to IPCA, Silvassa Cites Lapses

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

Qvents
May 18, 2023