www.fdanews.com/articles/188673-fda-cites-jeio-tech-for-complaint-handling-procedure
FDA Cites Jeio Tech for Complaint Handling Procedure
October 4, 2018
The FDA slapped devicemaker Jeio Tech with a Form 483 for deficient complaint handling at its Billercia, Massachusetts facility.
The agency’s inspection from May 1-2 found that the firm’s complaint handling procedure did not include steps for evaluating a complaint to determine whether it warrants a medical device report.
The firm also lacked written medical device report procedures, test and inspection data for service records and procedures for preventing electrostatic discharge while servicing and repairing electronics.