FDA Observes Lack of MDR Procedures at BZ Medical

Written MDR procedures had yet to be developed at BZ Medical when the FDA conducted an August inspection at the medical device specifications developer’s facility in Portland, Oregon.

The firm’s complaint procedure was found to be inadequate in that it lacked provisions for conducting a standardized review of complaints to determine whether an MDR was required and for timely MDR submissions to the FDA, as well as documentation and recordkeeping requirements, the agency’s investigator observed in a Form 483.

Other identified nonconformities relate to the firm’s product purchasing procedures – deemed inadequate as its subcontractors had not been evaluated since 2015 or at all – internal quality audits not being conducted since 2012, and its procedures for device history records, which did not include a requirement for documenting labeling.