# FDA 483 - Sun Ten Pharmaceutical Co., Ltd - December 19, 2017

Source: https://www.keypedia.com/records/483/sun-ten-pharmaceutical-co-ltd/19792906-12f2-44a7-ad69-ef71bcc40544

> FDA 483 for Sun Ten Pharmaceutical Co., Ltd on December 19, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Ten Pharmaceutical Co., Ltd
- Inspection Date: 2017-12-19
- Product Type: other
- Office Name: Office of Compliance Intervention and Consultation
- Summary: An FDA inspection of Sun Ten Pharmaceutical Co., Ltd. in Taichung City, Taiwan, a dietary supplement manufacturer, revealed issues with equipment design and maintenance. Specifically, the firm failed to use equipment that could be adequately cleaned and properly maintained, citing exposed screw threads and rough welds on direct food contact surfaces of tanks and concentrators. This indicates a moderate severity finding related to manufacturing practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jane-chen/4f0b3c6c-44e9-4db4-a140-4c1d5761ee55)

Company: https://www.keypedia.com/companies/sun-ten-pharmaceutical-co-ltd/2223b5f3-7430-4b96-ad76-7f3f0a8ef361

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54