# FDA 483 - Zhangzhou Aoxi Plastics Co., Ltd. - December 06, 2017

Source: https://www.keypedia.com/records/483/zhangzhou-aoxi-plastics-co-ltd/128590cd-9df6-4e4a-93e9-73c76709819d

> FDA 483 for Zhangzhou Aoxi Plastics Co., Ltd. on December 06, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhangzhou Aoxi Plastics Co., Ltd.
- Inspection Date: 2017-12-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Zhangzhou Aoxi Plastics Co., Ltd. in Zhangzhou, China, a medical device manufacturer, revealed a significant issue regarding process validation. The firm failed to adequately validate processes for manufacturing hospital disposable devices. This indicates a lack of assurance in the consistency and quality of their production methods.

## Related Officers

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

Company: https://www.keypedia.com/companies/zhangzhou-aoxi-plastics-co-ltd/99be2014-c32f-4c1f-9628-d8441ea0ae0e

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