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Aurobindo Pharmaceutical Limited's drug manufacturing facility in India was cited for significant deviations from current good manufacturing practice (CGMP) standards for active pharmaceutical ingredients (APIs), rendering their products adulterated. During an August 2021 inspection, the FDA identified a critical failure to adequately evaluate how increasing acceptable limits for impurities in an API starting material would affect the quality of the final API—the company raised specification limits based on incomplete lab-scale studies that did not assess all potential impurities that could be generated. Rather than conducting a comprehensive impact analysis, Aurobindo relied on insufficient data to justify the specification changes, creating potential quality and safety risks in their drug products.