MYM Hidrominerales S.A. de C.V. Warning Letter Details

Summary

MYM Hidrominerales S.A. de C.V. was warned for manufacturing Protz real protection ANTIBACTERIAL HAND SANITIZER, an unapproved new drug that was adulterated due to substance substitution and misbranded under multiple FD&C Act sections. FDA laboratory testing of a batch detained at the U.S. border found that the product's quality assurance and manufacturing practices failed to meet Current Good Manufacturing Practice (CGMP) requirements, demonstrating inadequate controls over the manufacturing process. The company's facility lacked proper quality assurance systems to ensure the product's integrity and compliance with regulatory standards for human drug manufacture.