483
Huiqiang Sun HuangHuiqiang Sun Huang – FDA 483, Feb 14, 2025
Record Details
An FDA inspection of Yet-Sen University Cancer Center's clinical research facility in Guangzhou, China, revealed significant deviations from its investigational plan. Deficiencies included inadequate subject file documentation, improper study drug handling and storage, and insufficient staff training in Good Clinical Practice. These findings indicate a systemic failure to adhere to proper clinical trial procedures, potentially impacting subject safety and data integrity.
View Company Profile
ID · e12f0a35-ccdf-4b6b-82ab-1eb5fb398442
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.