Grupo Yacana Mexico, S.A.S. de C.V. Warning Letter Details

Summary

Grupo Yacana Mexico was cited for manufacturing unapproved and misbranded antiseptic hand rub products labeled as containing 70% alcohol that were detained at the U.S. border. FDA laboratory testing found the products were adulterated due to substitution of active ingredients (section 501(d)(2) of the FD&C Act) and in one batch, substandard strength, purity, or quality (section 501(c)). The company had recently registered as a human drug manufacturer but failed to ensure its hand sanitizer products met required specifications and were properly approved for U.S. distribution.