# FDA 483 - Xinxiang Tuoxin Pharmaceutical Co. Ltd - October 18, 2021

Source: https://www.keypedia.com/records/483/xinxiang-tuoxin-pharmaceutical-co-ltd/e3cddd0f-9c6a-43cd-b158-071155413a75

> FDA 483 for Xinxiang Tuoxin Pharmaceutical Co. Ltd on October 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xinxiang Tuoxin Pharmaceutical Co. Ltd
- Inspection Date: 2021-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Xinxiang Tuoxin Pharmaceutical Co., Ltd., a drug intermediates manufacturer in Xinxiang, China, was cited for significant quality control deficiencies during an FDA inspection. Observations included poorly maintained manufacturing equipment with potential for product contamination, unvalidated laboratory analytical methods, and inadequate investigation of deviations. Furthermore, the firm lacked proper electronic controls for data integrity in computerized systems.

## Related Documents

- [483 - 2019-06-06](https://www.keypedia.com/records/483/xinxiang-tuoxin-pharmaceutical-co-ltd/8eff03f5-2bc3-4e9a-95ce-4be2647445c7)

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.keypedia.com/companies/xinxiang-tuoxin-pharmaceutical-co-ltd/ba373358-5a25-46e6-a497-d61d94d78862

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1