# FDA 483 - ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS) - July 20, 2016

Source: https://www.keypedia.com/records/483/zhongshan-aj-medical-equipment-co-ltd-jbs/f4525cad-3fcb-4b40-886b-1d619244baf5

> FDA 483 for ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS) on July 20, 2016. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS)
- Inspection Date: 2016-07-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.keypedia.com/companies/zhongshan-aj-medical-equipment-co-ltd-jbs/27bd6354-fedf-4e3b-b125-8f85b90bcdb4

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd