Landy International – FDA Warning Letter, Dec 14, 2023

On June 12, 2024, the FDA issued Warning Letter 320-24-43 to Landy International, a drug manufacturing facility in Xiamen, China, following an inspection from December 11-14, 2023. The letter details significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test finished drug products:** The firm did not adequately test OTC hand sanitizers for active ingredient (ethanol) identity and strength before release, a repeat observation from a 2017 inspection (21 CFR 211.165(a)). 2. **Inadequate component testing:** The firm failed to test each component lot for identity, purity, strength, and quality, and did not validate supplier COAs (21 CFR 211.84(d)(1) and 211.84(d)(2)). Specifically, incoming ethanol was not tested for methanol, and glycerin was not adequately tested for diethylene glycol (DEG) or ethylene glycol (EG). 3. **Deficient water system:** The water system was not adequately designed, monitored, or maintained, with stagnant water, biofilm, leaks, and pooling observed. Cleaning and monitoring