# FDA 483 - Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd. - May 21, 2021

Source: https://www.globalkeysolutions.net/records/483/jiangsu-sihuan-bioengineering-pharmaceutical-co-ltd/82ec5d29-5e87-4077-aa09-a17c7ff59034

> FDA 483 for Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd. on May 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd.
- Inspection Date: 2021-05-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd., a drug manufacturer, and issued a Form 483 with five observations. Significant issues were identified concerning data integrity, including missing electronic raw data and inadequate backup procedures for laboratory instruments. Additionally, the firm lacked appropriate controls over computerized systems, failed to establish scientifically sound test procedures for impurities, and did not properly qualify essential manufacturing equipment or implement adequate change control procedures.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/jiangsu-sihuan-bioengineering-pharmaceutical-co-ltd/aed6cd24-bc07-4872-9a00-351ac2e26692

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