Xi'an Livingbond Nonwoven Products Corp., Ltd. – FDA Warning Letter, Jan 10, 2019

The FDA issued a Warning Letter to Xi’an Livingbond Nonwoven Products Corp., Ltd. following an inspection from January 7-10, 2019, identifying significant CGMP violations for finished pharmaceuticals, specifically Antibacterial Wet Wipes. The products are deemed adulterated under 21 U.S.C. 351(a)(2)(B) and misbranded under 21 U.S.C. 352(x).

Key violations include: 1. **Lack of finished product testing:** The firm failed to test each batch for identity, strength, and objectionable microorganisms before release (21 CFR 211.165(a) and (b)). Their response was inadequate as it lacked corrective actions for products already on the market, details on third-party testing, or procedures. 2. **Inadequate component testing:** The firm failed to test incoming active pharmaceutical ingredients (API) and other components for identity, purity, and strength, relying solely on supplier certificates of analysis without validation (21 CFR 211.84(d)(1) and (2)). Their response was insufficient, not committing to test each raw material lot or specifying supplier validation methods. 3. **Absence of validated production and process controls:** The firm lacked written procedures for production and process control, including process validation for manufacturing and the water system (21 CFR 211