FDA WARNING_LETTER - Inovaker Lab S.A. de C.V. - September 23, 2020

The FDA issued a Warning Letter to Luis Quintanar Poniente, registered as a human drug manufacturer, regarding their Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution. The product, declared to be manufactured at Inovaker Lab S.A. de C.V., was detained at the U.S. border.

FDA testing revealed the product contained 0% ethyl alcohol, despite being labeled as 75% v/v. This renders the product adulterated under section 501(c) of the FD&C Act due to subpotency, and 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. Furthermore, it is an unapproved new drug (505(a)) and misbranded (502(a) and (ee)) because it is not GRASE, lacks FDA approval, and its labeling is false and misleading. The product does not conform to the 1994 Tentative Final Monograph or temporary COVID-19 policies for hand sanitizers.

The FDA recommended a recall on September 23, 2020, which has not been initiated. The firm claimed identity theft on October 13, 2020. The FDA publicly notified of the subpotency on September 24, 2020.

Required corrective actions include a detailed investigation into the 0% ethanol finding,