Drivergent, Inc. – FDA Warning Letter, Nov 3, 2022

On May 1, 2023, the FDA issued Warning Letter WL #647234 to Drivergent, Inc. following an inspection from October 31 to November 3, 2022, at their Fraser, MI drug manufacturing facility. The letter states that FDA laboratory testing of Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution (Lots L30 and L31) found unacceptable levels of acetaldehyde (221 ppm and 211 ppm, respectively) and acetal (575 ppm and 578 ppm, respectively), exceeding the USP limit of 10 ppm for acetaldehyde and acetal (expressed as acetaldehyde). This indicates the drug products are adulterated under section 501(a)(2)(B) of the FD&C Act due to quality assurance not conforming to CGMP requirements.

The letter also cites several CGMP violations: 1. Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.165(a)). 2. Failure to conduct at least one test to verify the identity of each component and validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)), specifically for ethyl alcohol and glycerin, which pose