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Jagsonpal Pharmaceuticals Limited received a warning letter for manufacturing adulterated active pharmaceutical ingredients (APIs) that failed to comply with Current Good Manufacturing Practice (CGMP) standards. During inspections conducted in March and April 2024, the FDA identified significant deviations including the company's failure to ensure its contract manufacturing organization (CMO) complied with CGMP requirements, and the use of an unregistered CMO that was not properly listed with the FDA as required by federal law. The company's quality unit failed to exercise adequate responsibility for overseeing manufacturing, processing, and packaging activities performed by the CMO, and the firm incorrectly declared itself as the manufacturer on import records while the actual CMO remained unregistered with the FDA.