FDA states that its March 2–5, 2026, inspection of Suretec Innovations’ Arizona facility found significant CGMP violations in OTC drug manufacturing. The firm did not adequately identity-test incoming components, including the API, and relied on supplier certificates of analysis without establishing their reliability. FDA also found inadequate finished-product microbiological testing: the non-compendial method lacked appropriate incubation times, method suitability, controls, and validation. The quality unit did not thoroughly investigate microbial out-of-limit results from a system supplying a manufacturing component; material from that system continued to be used in products that were released. FDA further found that the quality unit lacked adequate authority and oversight, including for production and process procedures, system qualification, stability testing, defined quality-unit responsibilities, and sufficient qualified personnel. FDA judged the firm’s responses inadequate because they lacked key documentation, implemented investigation controls, and retrospective assessments of distributed product quality. FDA requested material-system and supplier reviews, component and retain-sample testing, investigation remediation, risk assessment, CAPA, and comprehensive quality-unit remediation.