# FDA WARNING_LETTER - Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd. - April 15, 2022

Source: https://www.keypedia.com/records/warning_letter/beijing-xinggu-lvsan-technology-co-ltd-formerly-known-as-beijing-lvsan-technology-co-ltd/53354f03-0c0f-46fc-90aa-ce75bf792172

> FDA WARNING_LETTER for Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd. on April 15, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd.
- Inspection Date: 2022-04-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued Warning Letter 320-23-01 to Beijing Xinggu Lvsan Technology Co., Ltd. on October 5, 2022, following an inspection from April 11-15, 2022. The letter details significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products, including SierraSoft Alcohol Hand Sanitizer and SierraSoft Non-Alcohol Foam Hand Sanitizer, adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1. **Failure to test components for identity and validate supplier analyses** (21 CFR 211.84(d)(1) and 211.84(d)(2)). The firm used unqualified supplier COAs and did not adequately test incoming components.
2. **Failure to establish adequate cleaning and maintenance procedures for equipment** (21 CFR 211.67(b)). The firm uses the same equipment for drug and non-drug industrial products, posing a cross-contamination risk.
3. **Failure to conduct microbial testing on finished drug products** (21 CFR 211.165(b)).
4. **Failure to establish written procedures for production and process control to assure drug product quality**, including lack of process validation (21 CFR 211.100

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Emily Wu](https://www.keypedia.com/people/emily-wu/99c14d7f-b7cc-4364-a43a-5f9fed918fab)

Company: https://www.keypedia.com/companies/beijing-xinggu-lvsan-technology-co-ltd-formerly-known-as-beijing-lvsan-technology-co-ltd/7c060fe9-4cd9-4b83-9238-51aa7d6566d5

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c