FDA WARNING_LETTER - Urban Electric Power - July 28, 2022

On December 27, 2022, the FDA issued Warning Letter #635791 to Urban Electric Power, a manufacturer of OTC drug products, including consumer hand sanitizers. The facility, FEI 3016759092, located at 401 N Middletown Road, Bldg. 155, Pearl River, NY, was registered with the FDA until October 24, 2022, and distributed hand sanitizer products as recently as August 31, 2022.

FDA laboratory testing of four batches of "ohm BY URBAN ELECTRIC POWER" hand sanitizer and sanitizer spray found unacceptable levels of acetaldehyde and acetal impurities, exceeding the USP limit of 10 ppm. These impurities indicate that the facility's quality assurance is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements, rendering the drug products adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).

Furthermore, the company's September 8, 2022, response to an FDA information request revealed a violation of CGMP (21 CFR 211.170(b)) as they "do not have retain samples and therefore cannot test them to determine batch quality." The FDA expressed concern about the quality of all distributed hand