Neoingenium Labs, SA de CV Warning Letter Details

Summary

Neoingenium Labs, SA de CV was warned for manufacturing an unapproved hand sanitizer product called "cleansepure" that was detained at the U.S. border. FDA laboratory testing found the product was adulterated because it did not contain the declared 70% ethanol concentration, indicating a substitute substance was used, and revealed that the company's quality assurance and Current Good Manufacturing Practice (CGMP) controls were not functioning adequately. The product was also found to be misbranded under multiple FD&C Act sections and constituted an unapproved new drug introduced into interstate commerce.