# FDA 483 - Steris Corporation - March 13, 2020

Source: https://www.keypedia.com/records/483/steris-corporation/512f6156-a979-4432-b173-0956d1d05b72

> FDA 483 for Steris Corporation on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steris Corporation
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Steris Corporation in Mentor, OH, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish procedures for installation, change control, design transfer, training, and document control. These issues indicate a lack of robust control over critical processes for their medical devices, including the Innowave Ultrasonic Irrigators.

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)
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Company: https://www.keypedia.com/companies/steris-corporation/e8aec574-95a0-48ab-9dbb-c2a8884ec770

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22