FDA 483 - Allwell Medical Corporation - July 02, 2019

An FDA inspection of Allwell Medical Corporation in Raleigh, NC, conducted from July 1-2, 2019, revealed significant deficiencies in the firm's document control procedures. The inspection found that complaint handling processes were not adequately maintained and lacked proper authorization, and that the firm failed to record descriptions of changes made to quality procedures. These issues indicate a lack of established and controlled documentation within the quality system.