Larken Laboratories, Inc.: cGMP Deviations: The manufacturer failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice requirements.; cGMP Deviations; The manufacturer failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manuf

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Sources: FDA iRES · Raw API Response

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