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True Chemical Solutions, LLC manufactured OTC hand sanitizer products but failed to respond to FDA records requests sent via electronic communication in November 2020 and certified mail in May 2021, violating section 301(e) of the Federal Food, Drug, and Cosmetic Act. The company's non-compliance prevented FDA from assessing quality assurance measures at the facility during a period when numerous hand sanitizer products were being recalled due to quality defects including drug substance substitution and subpotency. The FDA's enforcement action was prompted by heightened regulatory scrutiny of hand sanitizer manufacturers following the COVID-19 public health emergency.