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The inspection revealed multiple violations of the Quality System Regulation, with the FDA stating these devices "are adulterated within the meaning of section 501(h) of the Act" because "the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements." Corrective action failures FDA identified critical failures in Zoll's corrective and preventive action procedures

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