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Home » AMF CITED FOR UNAPPROVED PMA, cGMP VIOLATIONS
AMF CITED FOR UNAPPROVED PMA, cGMP VIOLATIONS
December 3, 2004
Medical device firm AMF Support Services received an FDA warning letter in November citing numerous failures on the part of the firm to acquire “premarket approval or a determination of substantial evidence” for its Cool Heat Versatility Heating Mattress System.