FDA 483 - Lucero Medical LLC - September 07, 2022

Lucero Medical LLC, a medical device manufacturer in Richfield, OH, received five observations during an FDA inspection from August 29 to September 7, 2022. The inspection revealed significant deficiencies in quality system controls, including the absence of a design history file, inadequate labeling procedures, inconsistent risk analysis, a lack of internal quality audits for over nine years, and undefined supplier controls. Several of these issues were repeat observations from a previous inspection in 2013, indicating persistent non-compliance.