ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS) – FDA 483, Jul 20, 2016
An FDA inspection of Zhongshan A & J Medical Equipment Co., Ltd. (JBS), a medical device manufacturer in Zhongshan City, Guangdong, China, revealed significant deficiencies in their quality management system. The firm was cited for inadequate corrective and preventive action procedures, statistically invalid sampling plans for raw materials and finished devices, and poorly maintained device history records. These observations indicate a need for substantial improvements in their quality processes.
- Inspection date
- July 20, 2016
- Product type
- device
ID · f4525cad-3fcb-4b40-886b-1d619244baf5
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.