Neoingenium Labs, SA de CV

Warning LetterOpen

Mr. Alejandro Ortega CEO Neoingenium Labs, SA de CV Periferico Manuel Gomez Morin No. 6370 Ciudad Granja 45010 Zapopan , Jal. MexicoFEI 3013359123Issued Mar 31, 2021Center for Drug Evaluation and Research

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013359123.

Violations4

Issue DateMar 31, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Neoingenium Labs, SA de CV
Location: Mr. Alejandro Ortega CEO Neoingenium Labs, SA de CV Periferico Manuel Gomez Morin No. 6370 Ciudad Granja 45010 Zapopan , Jal. Mexico
FEI Number: 3013359123
Country: Mexico
Issue Date: March 31, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

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.

Neoingenium Labs, SA de CV FDA Warning Letter, March 31, 2021