FDA 483 - Vortex Surgical Inc. - February 09, 2023

Vortex Surgical Inc., a manufacturer of sterilized single-use ophthalmic surgical instruments in Saint Charles, MO, was cited for inadequate process validation. The firm failed to revalidate its sterilization procedure after relocating its operations and documented out-of-specification temperature and humidity readings during a sterilization validation, without proper analysis. This indicates a significant lapse in ensuring the effectiveness of their sterilization process.