Notarika, S.A. de C.V. Warning Letter Details

Summary

Notarika, S.A. de C.V. was warned for manufacturing Greenfrog Hand Sanitizer, an unapproved new drug that violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including being adulterated due to ingredient substitution and failing to meet Current Good Manufacturing Practice (CGMP) quality assurance requirements. FDA laboratory testing of batches detained at the U.S. border confirmed that the product contained substituted substances, demonstrating inadequate quality control at the facility. The product was also found to be misbranded under multiple FD&C Act sections related to labeling and drug approval status.