Laboratorios Jaloma S.A. de C.V. Warning Letter Details

Summary

Laboratorios Jaloma S.A. de C.V. was cited for manufacturing Jaloma Antiseptic Hand Sanitizer, an unapproved new drug that was adulterated due to substance substitution and failed quality assurance controls that violated Current Good Manufacturing Practice (CGMP) requirements. The product was detained and refused admission at the U.S. border following FDA laboratory testing that confirmed the adulteration. The hand sanitizer was also found to be misbranded under multiple FD&C Act sections and introduced into interstate commerce without required approval, violating sections 505(a) and 301 of the FD&C Act.