FDA WARNING_LETTER - Incredible Products, SA de CV - May 27, 2021

The FDA issued a Warning Letter to Incredible Products S.A. de C.V. on May 27, 2021, following the detention and refusal of admission of their GELBACT ANTIBACTERIAL HAND GEL product at the U.S. border. FDA testing revealed the product, labeled to contain 80% ethanol, actually contained an average of 1.2% ethanol and 67% methanol.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with dangerous methanol, and under 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. The product is also an unapproved new drug (505(a)) and misbranded (502(j), (a), (e), (x), (ee)) because it is dangerous, falsely labeled regarding active ingredients, fails to list methanol, lacks a domestic contact for adverse events, and does not comply with OTC marketing requirements.

The FDA recommended the firm engage a qualified CGMP consultant to evaluate operations, conduct a comprehensive audit, and assess corrective actions. The firm was already placed on Import Alert 66-78 on August 13, 2020. Incredible Products S.A. de C.V. must respond within 15 working days, detailing corrective actions, an investigation into the methanol substitution, a