FDA 483 - Resolution Biomedical Inc - December 12, 2019

An FDA inspection of Resolution Biomedical Inc, a medical device repackager in Tustin, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for finished device acceptance, corrective and preventive actions, and purchasing controls. These issues indicate a systemic breakdown in maintaining quality standards for their repackaged medical devices.