# FDA 483 - Beijing Xinggu Lvsan Technology Co., Ltd - April 11, 2022

Source: https://www.globalkeysolutions.net/records/483/beijing-xinggu-lvsan-technology-co-ltd/bb53e0f8-093e-4d67-8029-b408d7bcde45

> FDA 483 for Beijing Xinggu Lvsan Technology Co., Ltd on April 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beijing Xinggu Lvsan Technology Co., Ltd
- Inspection Date: 2022-04-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Beijing Lvsan Technology Co., Ltd., a drug manufacturer in Pinggu District, Beijing, revealed significant deficiencies in their quality control unit, data management, and manufacturing processes for hand sanitizers intended for the US market. The firm failed to establish written procedures, validate processes and equipment, perform adequate testing on raw materials and finished products, and maintain proper batch records. These issues indicate a severe lack of adherence to Good Manufacturing Practices.

## Related Documents

- [483 - 2022-04-11](https://www.globalkeysolutions.net/records/483/beijing-xinggu-lvsan-technology-co-ltd/7331bb97-02bc-4343-9109-58c6fa6c6158)

## 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/beijing-xinggu-lvsan-technology-co-ltd/955d1d07-8a07-45c2-9132-5d4b5e2f5d7f

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