FDA WARNING_LETTER - Global Sanitizers LLC - March 01, 2021

On November 8, 2021, the FDA issued a Warning Letter to Global Sanitizers LLC following a February 23 to March 1, 2021, inspection of their Las Vegas, Nevada drug manufacturing facility. The inspection was prompted by the firm's failure to respond to two prior record requests.

The FDA found significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Specifically, FDA testing revealed that "MEDICALLY MINDED Hand Sanitizer Gel Antimicrobial Formula" and "MEDICALLY MINDED Hand Sanitizer Gel Antimicrobial with Vitamin E & Moisturizer" were adulterated under section 501(d)(2) of the FD&C Act, as the active ingredient ethanol was substituted wholly or in part with methanol, a toxic substance. One product contained 0% ethanol and 58% methanol, while another had 32% ethanol and 7.4% methanol. The firm initiated a voluntary recall in May 2021 due to methanol presence.

CGMP violations included the quality control unit's failure to ensure compliance and product specifications (21 CFR 211.22). The firm lacked written procedures for the Quality Unit (QU), adequate personnel for quality oversight,