AriBio H&B Co., Ltd. Warning Letter Details

Summary

AriBio H&B Co., Ltd. was cited for manufacturing a hand sanitizer product labeled to contain 70% ethanol that failed FDA laboratory testing, demonstrating subpotency that violated Current Good Manufacturing Practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act. The product was also found to be adulterated under section 501(c) because its strength, purity, or quality fell below representations, and misbranded under sections 502(a) and (x). The violations were identified when a batch of Hand Sanitizer Original was detained and refused admission at the U.S. border, with quality assurance deficiencies further substantiated by the company's inadequate response during a November 2020 teleconference with FDA.