FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) - January 16, 2024
Discuss this record with AI
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.
Jiangsu Hengrui Pharmaceuticals Co., Ltd (Huanghe Road Site) received an FDA Form 483 with eight observations during an inspection from January 8-16, 2024. The inspection revealed significant deficiencies in aseptic processing validation, cleaning validation, container closure integrity testing, and quality unit oversight. Furthermore, issues included inadequate data integrity, lack of control over computerized systems, poor facility maintenance, and obstruction during the inspection.
- Inspection Date
- January 16, 2024
- Product Type
- Drugs
ID · f1c77da3-4ebf-4928-83f6-164ebfa4bbe0