Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
