FDA 483 - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. - September 13, 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.
An FDA inspection of Shanghai Chuangshi Medical Technology (Group) Co., Ltd., an OTC human drug manufacturer in Qingpu District, Shanghai, China, revealed significant deficiencies in quality control. Observations included an inadequate stability program lacking impurity testing and stability-indicating methods, failure to perform identity testing for drug product components, and insufficient procedures to prevent objectionable microorganisms. These issues indicate a lack of assurance regarding drug product quality and safety.
- Inspection Date
- September 13, 2024
- Product Type
- Drugs
ID · 889a3bc6-c368-45d3-9b9d-e3e303847add