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Fei Fah Medical Manufacturing Pte. Ltd., a Singapore-based OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to establish and follow adequate written stability testing programs to assess drug product stability characteristics, determine appropriate storage conditions, and assign scientifically supported expiration dates, as required by 21 CFR 211.166(a). Specifically, the firm lacked adequate stability data to support assigned expiration dates for certain drug products and had not established specifications or used stability-indicating methods to test for impurities and degradants. The company's response to the FDA's initial observations was deemed inadequate.