FDA 483 - Fuller Industries, Inc - February 17, 2023

Fuller Industries, Inc., an Over-the-Counter (OTC) manufacturer, underwent an FDA inspection from February 15-17, 2023. The inspection resulted in seven observations detailed on an FDA Form 483, indicating significant deviations from regulatory expectations, specifically Current Good Manufacturing Practices (cGMP). Major issues identified include inadequate laboratory controls, where analytical test methods were unvalidated, procedures were uncontrolled, and out-of-specification (OOS) assay results for active ingredients in antibacterial hand soap were not properly investigated or reviewed. The company also lacked a written program for assessing drug product stability, providing insufficient data and missing raw information to support product expiration dates. Critically, products failing established specifications were not rejected, with OOS pH and assay results for antibacterial hand soap being released for distribution without formal investigation. Further observations included deficient laboratory records lacking proper sample identification, the absence of procedures for annual product reviews, unapproved Standard Operating Procedures (SOPs), and inadequate component testing, as the company accepted supplier analyses without performing identity tests or supplier qualification. Fuller Industries, Inc. is required to implement comprehensive corrective actions to address these systemic deficiencies and ensure full compliance with regulatory standards.