# FDA 483 - NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. - July 25, 2013

Source: https://www.keypedia.com/records/483/ningbo-tianyi-medical-appliance-co-ltd/21d8062a-2823-4ba5-8010-5b684d8a7d9a

> FDA 483 for NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. on July 25, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
- Inspection Date: 2013-07-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. in NINGBO, China, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for process changes, specifically lacking documented justification for revalidation decisions. Additionally, procedures for the acceptance of in-process products were not established, leading to the use of out-of-specification components in finished medical devices.

## Related Officers

- [Rodney B Ross](https://www.keypedia.com/people/rodney-b-ross/9f3ff4ea-44c9-4e60-9850-7d9fd6b00008)

Company: https://www.keypedia.com/companies/ningbo-tianyi-medical-appliance-co-ltd/bc032b7b-e607-4380-9fb5-ac869c2daa3f

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