Drivergent, Inc. – FDA 483, Nov 3, 2022

Drivergent, Inc., an OTC drug manufacturer in Fraser, MI, was cited for severe deficiencies across its quality system during an FDA inspection. The firm lacked a functional Quality Control Unit, failed to establish critical written procedures for manufacturing, testing, and stability, and operated with inadequate facility maintenance. These issues indicate a fundamental lack of adherence to CGMP requirements for hand sanitizer production.