FDA 483 - Liquid Crystal Resources Hallcrest LLC - October 01, 2019

Liquid Crystal Resources Hallcrest LLC, a manufacturer in Glenview, IL, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate validation of software and manufacturing processes, deficiencies in corrective and preventive action procedures, and incomplete device history records. The firm also failed to adequately manage complaints and maintain device master records, indicating systemic issues in its quality management system.