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Analytical Food Laboratories, Inc., a contract testing laboratory, was cited for significant Current Good Manufacturing Practice (CGMP) violations in its testing of finished pharmaceutical products, rendering those drugs adulterated. The company failed to establish and follow required laboratory control mechanisms, including the validation of analytical methods used to test over-the-counter drug products and the establishment of adequate system suitability procedures for high-performance liquid chromatography testing. Specifically, the firm conducted assay testing without written procedures or validated test methods, creating deficiencies in the scientifically sound specifications and test procedures required to ensure drug product quality and purity.