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

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