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

Source: https://www.globalkeysolutions.net/records/483/beijing-xinggu-lvsan-technology-co-ltd/7331bb97-02bc-4343-9109-58c6fa6c6158

> 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: Division of Advertising & Promotion 
- Summary: Beijing Lvsan Technology Co., Ltd., a drug manufacturer in Pinggu District, Beijing, CN, was cited for significant deficiencies across its quality control unit, laboratory operations, and manufacturing processes. The inspection revealed issues including inadequate data backup, lack of component identification testing, absence of a stability study program, and unvalidated manufacturing processes for OTC hand sanitizers. Additionally, the firm failed to establish written cleaning procedures for non-dedicated equipment and lacked proper qualification for manufacturing equipment and laboratory controls.

## Related Documents

- [483 - 2022-04-11](https://www.globalkeysolutions.net/records/483/beijing-xinggu-lvsan-technology-co-ltd/bb53e0f8-093e-4d67-8029-b408d7bcde45)

## 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/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0