# FDA 483 - Datex-Ohmeda, Inc. - November 17, 2023

Source: https://www.globalkeysolutions.net/records/483/datex-ohmeda-inc/ae7bd228-04ad-49b9-879e-879b3847dc23

> FDA 483 for Datex-Ohmeda, Inc. on November 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Datex-Ohmeda, Inc.
- Inspection Date: 2023-11-17
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.globalkeysolutions.net/companies/datex-ohmeda-inc/c517cfc9-b6f5-47f3-af19-68a1c6b54d00

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d