Steris CorporationMay 23, 2022

FDA 483 - Steris Corporation - May 23, 2022

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Record Details

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.

Company: Steris Corporation
Inspection Date: May 23, 2022
Product Type: Device
Office: Cincinnati District Office
Person: Benjamin J. Dastoli (Investigator )

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ID · d8ea0d4f-24f1-4244-9ac5-84963611397e