FDA 483 - Orfit Industries NV - May 17, 2018

An FDA inspection of Orfit Industries NV, a medical device manufacturer in Wijnegem, Belgium, revealed significant deficiencies in their quality system. Observations included inadequate documentation of design review results for the RT-131, Mammo RX Breast Board, and insufficient frequency and documentation of management reviews. Additionally, the firm failed to perform quality audits covering all elements of the quality system, indicating a need for improved adherence to regulatory requirements.