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Medical Devices / Inspections and Audits

FDA Cites Jeio Tech for Complaint Handling Procedure

Oct. 5, 2018
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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.

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