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Seatex, LLC, a drug manufacturer in Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, specifically over-the-counter hand sanitizers, by failing to establish adequate written procedures for equipment cleaning and maintenance as required by 21 CFR 211.67(b). The company manufactured drug products on the same equipment used to produce non-pharmaceutical industrial chemicals such as floor cleaner, creating unacceptable cross-contamination risks, and could not provide cleaning validation studies or post-wash testing documentation to support their cleaning procedures. The FDA determined the company's drug products were adulterated and deemed their November 2023 response to the inspection findings inadequate for demonstrating corrective actions sufficient to achieve CGMP compliance.