FDA 483 - 4QImaging, LLC DBA Qmetrics - February 04, 2019

4QImaging, LLC DBA Qmetrics, a medical device manufacturer in Pittsford, NY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established written procedures for Medical Device Reporting (MDRs), handling customer complaints, and controlling non-conforming products. These observations indicate a fundamental failure to implement critical regulatory requirements for medical device manufacturing.