Simex Logistics S.A. de C.V. Warning Letter Details

Summary

Simex Logistics S.A. de C.V., a Mexican drug manufacturer, was cited for producing HEALTH & HAND GEL HAND SANITIZER, an unapproved new drug that was adulterated due to subpotency and inadequate quality assurance controls failing to meet Current Good Manufacturing Practice (CGMP) requirements. FDA laboratory testing of a detained batch revealed the product's strength, purity, and quality fell below represented levels, and the product was also found to be misbranded. The company violated multiple sections of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved drug into interstate commerce without authorization.