# FDA 483 - Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd. - January 14, 2020

Source: https://www.globalkeysolutions.net/records/483/chengdu-xinjin-shifeng-medical-apparatus-instrument-co-ltd/a4b0575e-7474-462f-ad6e-7e4677fc1b65

> FDA 483 for Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd. on January 14, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd.
- Inspection Date: 2020-01-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd. in Chengdu, China, revealed significant deficiencies in its quality system for medical devices. The firm failed to adequately establish procedures for complaint handling, sterilization validation, and design controls for its sterile Intravenous Sets and syringes intended for the US market. These issues are serious, especially given the firm's export of devices to the US without proper 510(k) clearance.

## Related Officers

- [Felix J. Marrero](https://www.globalkeysolutions.net/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.globalkeysolutions.net/companies/chengdu-xinjin-shifeng-medical-apparatus-instrument-co-ltd/62da477c-ca74-40fa-a16e-bba937233a16

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