FDA 483 - Microcision Llc - August 09, 2023

An FDA inspection of Microcision Llc in Pennsauken, NJ, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately validate cleaning and passivation processes for bone screws, lacked proper documentation for the implementation and effectiveness verification of corrective and preventive actions, and did not maintain complete device master records and device history records. These issues indicate a need for improved control over manufacturing processes and quality management documentation.