# FDA 483 - Steris Corporation - May 23, 2022

Source: https://www.keypedia.com/records/483/steris-corporation/d8ea0d4f-24f1-4244-9ac5-84963611397e

> FDA 483 for Steris Corporation on May 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steris Corporation
- Inspection Date: 2022-05-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Carefusion 2200 Inc, a medical device manufacturer in Middleburg Heights, OH, was inspected by the FDA. The inspection revealed significant issues with the firm's incoming inspection records and methods, specifically regarding the identification and maintenance of product acceptance status. This indicates a moderate level of concern regarding quality control and product release processes.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/steris-corporation/d3c31b27-afb0-43da-960f-dd3212d93119

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