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System Kosmetik Produktionsgesellschaft für kosmetische GmbH, a German drug manufacturer, failed to establish adequate written procedures for production, process control, and equipment cleaning/maintenance as required by Current Good Manufacturing Practice (CGMP) regulations. The facility could not provide documentation demonstrating that its over-the-counter drug products were validated to meet predetermined quality requirements consistently and reliably, and lacked qualification protocols, reports, or studies to support product identity, strength, quality, and purity claims. These manufacturing deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, resulting in significant CGMP violations identified during a February 2022 FDA inspection.