Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistUltra Chem Labs Corporation was warned on December 20, 2022, for manufacturing adulterated drug products and an unapproved new drug (Proton Armor Anti-Microbial Alcohol-Free Foaming Hand Sanitizer) in violation of Current Good Manufacturing Practice (CGMP) regulations. FDA inspectors found that the company's quality control unit failed to ensure drug products complied with CGMP standards and met established specifications during a July 2022 inspection. Although the company claimed to have discontinued production of the hand sanitizer in its response, it failed to provide specific evidence or details of corrective actions to address the FDA 483 observations.