FDA 483 - Cornerstone Laboratories LLC - January 19, 2023

Cornerstone Laboratories LLC, a contract testing lab in Memphis, TN, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality control unit, laboratory records, computer system controls, employee training, and instrument calibration, indicating a systemic lack of written procedures and proper oversight for critical operations. These issues collectively point to a serious breakdown in cGMP compliance, particularly concerning data integrity and quality assurance for OTC drug product testing.