# SINO MEDICAL SCIENCES TECHNOLOGY INC – FDA 483, Aug 24, 2023

Source: https://www.keypedia.com/records/483/sino-medical-sciences-technology-inc/74b56af8-a607-4f2a-948c-625a379b3af7

> FDA 483 for SINO MEDICAL SCIENCES TECHNOLOGY INC on August 24, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SINO MEDICAL SCIENCES TECHNOLOGY INC
- Inspection Date: 2023-08-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of SINO MEDICAL SCIENCES TECHNOLOGY INC, a medical device manufacturer in Tianjin, China, revealed three significant observations. The firm was cited for inadequate establishment and implementation of procedures for corrective and preventive actions, as well as deficiencies in developing and maintaining written Medical Device Reporting (MDR) procedures. Additionally, the inspection found that procedures for design validation had not been fully implemented.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/sino-medical-sciences-technology-inc/477da46b-f4cb-4bba-b4ef-914e54cb11e5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4