Failure to establish procedures for design changes and for acceptance of incoming product, were among the quality management lapses uncovered during a May 13-16 FDA inspection of Vasamed’s Eden Prairie, Minnesota plant.
The devicemaker manufacturers the Sensilase PAD-IQ, which measures skin perfusion to detect arterial vascular health.
Agency investigators found that design plans were not reviewed, updated and approved as the design and development of the device evolved. A user interface board design change for the PAD-IQ was completed in 2016, but documentation control procedures were not established.
Engineering change orders are required, and they should include a drawing, marketing literature, labeling, technical specification, work instruction, operating procedures, material specification and parts that are under control of the Vasamed documentation system, the agency said. However, this was not done for at least five major processes.
In addition, the device history record didn’t demonstrate that the device was manufactured in accordance with quality management practices, because none of the records included primary identification labeling.
The firm also identified issues with nonconforming product, but it had not opened a vendor action request to correct a complaint, as is required by its CAPA procedures.
Read the Form 483 here: www.fdanews.com/10-10-19-vasamedinc483.pdf.