FDA 483 - Euclid Systems Corporation - March 07, 2018

An FDA inspection of Euclid Systems Corporation, a contact lens manufacturer in Sterling, VA, revealed significant deficiencies across its quality system. The firm was cited for inadequate validation of manufacturing processes, poorly established corrective and preventive action procedures, and insufficient vendor evaluation. Additionally, issues were found with equipment calibration and maintenance documentation, indicating a broad lack of control over critical operations.