# FDA 483 - Hunan Vathin Medical Instrument Co., Ltd. - March 01, 2024

Source: https://www.keypedia.com/records/483/hunan-vathin-medical-instrument-co-ltd/a1a53ded-a8b5-4201-be00-46d354021905

> FDA 483 for Hunan Vathin Medical Instrument Co., Ltd. on March 01, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hunan Vathin Medical Instrument Co., Ltd.
- Inspection Date: 2024-03-01
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Hunan Vathin Medical Instrument Co., Ltd. in Xiangtan, China, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found that the firm had not established adequate procedures for design control, complaint handling, and corrective and preventive actions, indicating a lack of fundamental quality management processes for medical device manufacturing.

## Related Officers

- [(b) (6)](https://www.keypedia.com/people/b-6/f45e7378-264e-466f-9574-62de3798e233)

Company: https://www.keypedia.com/companies/hunan-vathin-medical-instrument-co-ltd/5b9debeb-1e89-436c-92e5-61a0c449e535

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