FDA 483 - CoRE labs, LLC - April 11, 2019

Cobi labs, LLC, a medical device manufacturer in Englewood, CO, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate design change procedures, unmaintained document control procedures with conflicting information, and a failure to submit required annual reports for certain products. These issues indicate a lack of robust control over product design, documentation, and regulatory compliance.