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

Source: https://www.keypedia.com/records/483/vortex-surgical-inc/6a2eb734-29f7-4b6f-9fbb-615065db644c

> FDA 483 for Vortex Surgical Inc. on February 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vortex Surgical Inc.
- Inspection Date: 2023-02-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2026-01-08](https://www.keypedia.com/records/483/vortex-surgical-inc/a9376118-52e1-40ff-b42c-af81dcece7cb)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/vortex-surgical-inc/a846fc3d-c055-4bfe-9dc6-17229b6b775a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8