# FDA 483 - Xiantao Shuangyan Plastics Co., Ltd. - May 02, 2018

Source: https://www.keypedia.com/records/483/xiantao-shuangyan-plastics-co-ltd/0aeaf1cb-a21a-4b7c-b10a-b86b83aae278

> FDA 483 for Xiantao Shuangyan Plastics Co., Ltd. on May 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xiantao Shuangyan Plastics Co., Ltd.
- Inspection Date: 2018-05-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Xiantao Shuangyan Plastics Co., Ltd., a foreign Class I medical device manufacturer in Xiantao City, Hubei Province, China, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate environmental controls, including widespread contamination in raw material storage and production areas, along with poor hygiene practices and facility maintenance. Additionally, the firm failed to conduct required internal quality audits for several years, indicating a systemic breakdown in their quality management system.

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/xiantao-shuangyan-plastics-co-ltd/1786872b-8c36-46b2-9fe3-9d15bc1713ef

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