FDA 483 - CoRE labs, LLC - June 21, 2023

CORe labs, LLC, a medical device manufacturer in Englewood, CO, was cited for four observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, specifically regarding procedures for complaint handling, design change control, management of nonconforming products, and document control. These issues indicate a systemic lack of adequate procedural establishment and documentation practices.