FDA 483 - International Contract Labs DBA Analytical Resource Laboratories LLC (St. Petersburg, FL) - November 24, 2025

International Contract Labs dba Analytical Resource Laboratories LLC, a contract testing laboratory in St Petersburg, FL, was cited for significant deficiencies in equipment validation, laboratory controls, and data integrity during an FDA inspection. Observations included inadequate validation of sterilization and incubation equipment, poor documentation and control of samples and testing procedures, and a lack of segregation of duties for computer system administrators. These issues indicate a systemic breakdown in quality control and compliance with cGMP regulations.