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Vi-Jon, LLC's manufacturing facility for over-the-counter drug products, including benzalkonium chloride-based hand sanitizer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA identified that the company failed to establish adequate laboratory controls with scientifically sound specifications and test procedures, specifically citing an insufficient water sampling plan that did not represent the overall system variability across all points of use in production operations. The company's response to FDA Form 483 observations was deemed inadequate due to lack of sufficient detail and evidence of corrective actions needed to achieve CGMP compliance, resulting in the drug products being classified as adulterated.