DiAgam Societe Anonyme (S.A.) – FDA 483, Mar 1, 2020

Diagam S.A. in Ghislenghien, Belgium, a manufacturer of Class II medical devices, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design control, supplier management, device labeling, document control, and incoming product acceptance procedures. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.