FDA 483 - Celestica Oregon, LLC. - October 25, 2019

Celestica Oregon, LLC, a contract manufacturer of Class II medical devices for ECG monitoring in Portland, OR, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for handling customer complaints, specifically lacking documentation for complaint investigations and device history record reviews. Additionally, the firm failed to adequately establish procedures for device history records, with multiple DHRs missing required identification and labeling elements.