FDA 483 - International Sterilization Laboratory, LLC - October 10, 2019

An FDA inspection of International Sterilization Laboratory, LLC, a medical device contract sterilizer in Groveland, FL, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow CAPA processes, including proper identification, documentation, and effectiveness verification of corrective actions. This indicates a fundamental breakdown in their quality system for addressing nonconformances and complaints.