FDA 483 - Vortex Surgical Inc. - February 09, 2023
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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.
ID · 6a2eb734-29f7-4b6f-9fbb-615065db644c