Datex-Ohmeda, Inc. – FDA 483, Nov 17, 2023

Datex-Ohmeda, Inc., a medical device manufacturer in Madison, WI, was inspected and cited for failing to adequately establish corrective and preventive action (CAPA) procedures. Specifically, the firm did not initiate CAPA for a potentially hazardous product nonconformance involving high formaldehyde levels in Giraffe incubators. This lapse was compounded by the firm's failure to consider relevant historical product testing data during its investigation, indicating a significant breakdown in their quality system.