Qvents

Qvents

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

Sichuan Deebio – 483, OAI and Warning

Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data

Chinese API Mfr Sichuan Deebio issued Wa

USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI

FDA 483 to Chinese API Manufacturer Sich

The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations

USFDA 483 / UCB Farchim SA/ June 2023 /

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

USFDA 483 / Intas / May 2023 /Failure to

USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Intas FDA 483 cites Manipulation of reco

FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection