Avioq, Inc. – FDA 483, Dec 5, 2023

Avioq, Inc. in Durham, NC, an In Vitro Device Diagnostic Manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to maintain adequate device history records for antigen aliquots used in IVD test kits. Additionally, observations noted a lack of established procedures for product identification during production and for controlling storage areas, leading to improper segregation of materials.