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APAP hepatotoxicity is the most frequent cause of acute liver failure (ALF) in the US [1] and a recent study evaluating outcomes in adults with acute liver failure between 1998 and 2013 indicates that hepatotoxicity due to APAP accounted for almost half the cases of ALF for the entire 16-year period, with unintentional APAP overdoses, (those in which patients took excessive medication over several days for ailments like pain or fever) being more common than intentional (suicidal) overdoses [2]
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For example, the warning letter issued to Vintage Chemical stated: “The qualified consultant should also perform a comprehensive six-system audit of your entire operation for cGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with the FDA.” 29 And, as in years past, in some letters, the FDA also reminds the firm that the “use of a consultant does not relieve your firm’s obligation to comply with cGMP
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